CINXE.COM

<!DOCTYPE html> <html lang="en" dir="ltr" prefix="og: https://ogp.me/ns#"> <head> <meta charset="utf-8" /> <script async src="https://www.googletagmanager.com/gtag/js?id=G-273DTKB5QW"></script> <meta name="description" content="Expiration dates and more about authorized at-home OTC COVID-19 diagnostic tests information." /> <meta name="dcterms.title" content="At-Home OTC COVID-19 Diagnostic Tests" /> <meta name="dcterms.creator" content="Center for Devices and Radiological Health" /> <meta name="dcterms.description" content="Expiration dates and more about authorized at-home OTC COVID-19 diagnostic tests information." /> <meta name="dcterms.publisher" content="FDA" /> <meta name="dcterms.type" content="Article" /> <meta name="dcterms.source" content="FDA" /> <meta property="og:site_name" content="U.S. Food and Drug Administration" /> <meta property="og:type" content="Article" /> <meta property="og:url" content="https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests" /> <meta property="og:title" content="At-Home OTC COVID-19 Diagnostic Tests" /> <meta property="og:description" content="Expiration dates and more about authorized at-home OTC COVID-19 diagnostic tests information." /> <meta property="og:updated_time" content="Mon, 11/18/2024 - 00:00" /> <meta property="article:publisher" content="FDA" /> <meta property="article:published_time" content="Mon, 11/18/2024 - 15:41" /> <meta property="article:modified_time" content="Mon, 11/18/2024 - 00:00" /> <meta name="google-site-verification" content="tWxlDhm4ANdksJZPj7TBmHgNoMqZCnecPp0Aa2vC9XA" /> <meta name="twitter:card" content="summary_large_image" /> <meta name="twitter:site" content="@US_FDA" /> <meta property="twitter:description" content="Expiration dates and more about authorized at-home OTC COVID-19 diagnostic tests information." /> <meta name="twitter:title" content="At-Home OTC COVID-19 Diagnostic Tests" /> <meta name="twitter:creator" content="@US_FDA" /> <meta name="MobileOptimized" content="width" /> <meta name="HandheldFriendly" content="true" /> <meta name="viewport" content="width=device-width, initial-scale=1.0" /> <script type="application/ld+json">{ "@context": "https://schema.org", "@graph": [ { "@type": "Article", "headline": "At-Home OTC COVID-19 Diagnostic Tests", "name": "At-Home OTC COVID-19 Diagnostic Tests", "description": "Expiration dates and more about authorized at-home OTC COVID-19 diagnostic tests information.", "datePublished": "Mon, 11/18/2024 - 15:41", "dateModified": "Mon, 11/18/2024 - 00:00", "author": { "@type": "Organization", "name": "Center for Devices and Radiological Health" }, "publisher": { "@type": "Organization", "name": "FDA" } } ] }</script> <meta property="og:image" content="https://www.fda.gov/themes/custom/preview/img/FDA-Social-Graphic.png" /> <meta name="twitter:image" content="https://www.fda.gov/themes/custom/preview/img/FDA-Social-Graphic.png" /> <link rel="icon" href="/themes/custom/preview/favicon.ico" type="image/vnd.microsoft.icon" /> <link rel="alternate" hreflang="en" href="https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests" /> <link rel="canonical" href="https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests" /> <link rel="shortlink" href="https://www.fda.gov/node/412786" /> <script src="/files/google_tag/production/google_tag.script.js?smjbjq" defer></script> <title>At-Home OTC COVID-19 Diagnostic Tests | FDA</title> <link rel="stylesheet" media="all" href="/files/css/css_9imYfj47K1t2vTOWSq90pbKkayA7se1ZmOedZ20axik.css?delta=0&language=en&theme=preview&include=eJxlT9GOwjAM-6GO3stJ_E2VtVmpaOuqyYHG17OB2IBTpMiyldieUJWuLChspx0fTARiZkeV8qzJi_0mjMyiXOxIwqZ1viS-2pgxUh5E55xq_Ef7npqKGQEV7dRsQ8OFu5kCOX_mkBTdcT1R9Vy4qljyHj0kVKeIawA5oatH2E2X4yGQLjNmlg_69fNdX0Wxj30oCH-Zn_YoLafV-Km535_jG2mmJXSFstgNbVa-023muBcO1D4ibqGHrc8deO2Utg" /> <link rel="stylesheet" media="all" href="/files/css/css_xLeUZALg1CD0YmiSIzZnqkwKfNF_g3TkAjkxBt_uccA.css?delta=1&language=en&theme=preview&include=eJxlT9GOwjAM-6GO3stJ_E2VtVmpaOuqyYHG17OB2IBTpMiyldieUJWuLChspx0fTARiZkeV8qzJi_0mjMyiXOxIwqZ1viS-2pgxUh5E55xq_Ef7npqKGQEV7dRsQ8OFu5kCOX_mkBTdcT1R9Vy4qljyHj0kVKeIawA5oatH2E2X4yGQLjNmlg_69fNdX0Wxj30oCH-Zn_YoLafV-Km535_jG2mmJXSFstgNbVa-023muBcO1D4ibqGHrc8deO2Utg" /> <script src="https://script.crazyegg.com/pages/scripts/0024/3700.js" async></script> <script src="https://dap.digitalgov.gov/Universal-Federated-Analytics-Min.js?agency=HHS&subagency=FDA&sdor=fda.gov&dclink=true" language="javascript" id="_fed_an_ua_tag"></script> <script>window.dataLayer = window.dataLayer || [];function gtag(){dataLayer.push(arguments)};gtag("js", new Date());gtag("set", "developer_id.dMDhkMT", true);gtag("config", "G-273DTKB5QW", {"groups":"default","page_placeholder":"PLACEHOLDER_page_location","allow_ad_personalization_signals":false});</script> </head> <body class="role-anonymous path-node page-node-type-article has-glyphicons"> <div id="quicklinks" class="sr-only"> <ul> <li><a href="#main-content" class="sr-only sr-only-focusable" tabindex="1">Skip to main content</a></li> <li><a href="#search-form" class="sr-only sr-only-focusable" tabindex="1">Skip to FDA Search</a></li> <li><a href="#section-nav" class="sr-only sr-only-focusable" tabindex="1">Skip to in this section menu</a></li> <li><a href="#footer-heading" class="sr-only sr-only-focusable" tabindex="1">Skip to footer links</a></li> </ul> </div> <noscript><iframe src="https://www.googletagmanager.com/ns.html?id=GTM-M95XGZW" height="0" width="0" style="display:none;visibility:hidden"></iframe></noscript> <div class="dialog-off-canvas-main-canvas" data-off-canvas-main-canvas> <div class="main-container container-fluid"> <div class="row"> <header class="lcds-header container-fluid" role="heading" aria-level="1"> <div class="row us-masthead"> <div class="usa-banner col-xs-12"> <img class="usa-banner__us-flag" src="/themes/custom/preview/assets/images/US_Flag.png" alt="U.S. flag" /> <span>An official website of the United States government</span> <a id="USMenuButton" class="collapsed" data-toggle="collapse" data-target="#USABannerMenu" aria-controls="USABannerMenu">Here’s how you know <span class="toggle-indicator"> </span></a> <div class="col-xs-12 collapse usa-banner__menu" id="USABannerMenu" aria-labelledby="USMenuButton"> <div id="gov-banner" class="row usa-banner-content usa-grid usa-accordion-content" aria-hidden="true"> <div class="col-xs-12 col-sm-6 col-md-3"> <img class="usa-banner-icon usa-media_block-img" src="/themes/custom/preview/assets/images/icon-dot-gov.svg" alt="Dot gov" style="width:3em;"> <div class="usa-media_block-body"> <p><strong>The .gov means it’s official.</strong><br>Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.</p> </div> </div> <div class="col-xs-12 col-sm-6 col-md-3"> <img class="usa-banner-icon usa-media_block-img" src="/themes/custom/preview/assets/images/icon-https.svg" alt="SSL" style="width:3em;"> <div class="usa-media_block-body"> <p><strong>The site is secure.</strong><br> The <strong>https://</strong> ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.</p> </div> </div> </div> </div> </div> </div> <div class="alert alert-warning margin-left-neg-2 margin-right-neg-2 margin-top-3 margin-bottom-1"> <p>On Oct. 1, 2024, the FDA began implementing a <a href="/about-fda/fda-organization/fda-modernization-efforts-establishing-unified-human-foods-program-new-model-field-operations-and" title="FDA Modernization Efforts for Establishing a Unified Human Foods Program, New Model for Field Operations and More">reorganization</a> impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.</p> </div> <div class="row fda-masthead"> <div class="col-xs-4 col-md-8"> <a href="/" title="FDA Homepage"> <h1 class="fda-masthead__fda-logo">U.S. Food and Drug Administration</h1> </a> </div> <div class="col-xs-8 col-md-4"> <ul class='fda-masthead__item-list'> <li><a title="" id="btn-search" class="btn btn-default btn-sm fda-masthead__btn-search"> <span class="fa fa-search" aria-hidden="true"> </span> <span class="fda-masthead__btn-label">Search</span> </a></li> <li><a id="menu-btn" class="btn btn-default btn-sm fda-masthead__btn-menu collapsed" href="#primary-nav" data-toggle="collapse" aria-expanded="true"> <span class="fa fa-bars" aria-hidden="true"> </span> <span class='fda-masthead__btn-label'>Menu</span> </a></li> </ul> </div> <form class="fda-masthead__search sr-only" role="search" action="/search" method="GET" name="searchForm" id="search-form" accept-charset="UTF-8" > <div class="search-popover" id="search-popover"> <div class="input-group pull-right" id="search-group"> <label class="sr-only" for="search-query">Search FDA</label> <input class="form-control search-input" id="search-query" name="s" aria-autocomplete="list" aria-haspopup="true" title="Enter the terms you wish to search for." placeholder="Search FDA" type="text" /> <span class="input-group-btn" id="input-group-btn"> <button type="submit" class="btn btn-danger search-btn" id="search-btn" title="Search"><span class="fa fa-search" aria-hidden="true"><span class="sr-only">Submit search</span></span></button> </span> </div> </div> </form> </div> <nav id="primary-nav" class="lcds-primary-nav row collapse"> <div class="col-md-5 col-lg-4"> <section class="lcds-primary-nav__group lcds-primary-nav__group--bordered"> <h2 class="lcds-primary-nav__group-heading">Featured</h2> <ul class="lcds-primary-nav__list lcds-primary-nav__list--featured"> <li class="lcds-primary-nav__list-item"><a href="https://www.safetyreporting.hhs.gov/smarthub#/" title="Report a Problem with an FDA Regulated Product">Report a Product Problem</a></li> <li class="lcds-primary-nav__list-item"><a href="/about-fda/contact-fda">Contact FDA</a></li> <li class="lcds-primary-nav__list-item"><a href="/regulatory-information/search-fda-guidance-documents">FDA Guidance Documents</a></li> <li class="lcds-primary-nav__list-item"><a href="/safety/recalls-market-withdrawals-safety-alerts">Recalls, Market Withdrawals and Safety Alerts</a></li> <li class="lcds-primary-nav__list-item"><a href="/news-events/newsroom/press-announcements">Press Announcements</a></li> <li class="lcds-primary-nav__list-item"><a href="/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters">Warning Letters</a></li> <li class="lcds-primary-nav__list-item"><a href="/advisory-committees">Advisory Committees</a></li> <li class="lcds-primary-nav__list-item"><a href="/fda-en-espanol">En Espa&#241ol</a></li> </ul> </section> </div> <div class="col-md-7 col-lg-8"> <section class="lcds-primary-nav__group lcds-primary-nav__group--bordered"> <h2 class="lcds-primary-nav__group-heading">Products</h2> <ul class="lcds-primary-nav__list"> <li class="lcds-primary-nav__list-item"><a href="/food">Food</a></li> <li class="lcds-primary-nav__list-item"><a href="/drugs">Drugs</a></li> <li class="lcds-primary-nav__list-item"><a href="/medical-devices">Medical Devices</a></li> <li class="lcds-primary-nav__list-item"><a href="/radiation-emitting-products">Radiation-Emitting Products</a></li> <li class="lcds-primary-nav__list-item"><a href="/vaccines-blood-biologics">Vaccines, Blood, and Biologics</a></li> <li class="lcds-primary-nav__list-item"><a href="/animal-veterinary">Animal and Veterinary</a></li> <li class="lcds-primary-nav__list-item"><a href="/cosmetics">Cosmetics</a></li> <li class="lcds-primary-nav__list-item"><a href="/tobacco-products">Tobacco Products</a></li> </ul> </section> <section class="lcds-primary-nav__group lcds-primary-nav__group--bordered"> <h2 class="lcds-primary-nav__group-heading">Topics</h2> <ul class="lcds-primary-nav__list"> <li class="lcds-primary-nav__list-item"><a href="/about-fda">About FDA</a></li> <li class="lcds-primary-nav__list-item"><a href="/combination-products">Combination Products</a></li> <li class="lcds-primary-nav__list-item"><a href="/regulatory-information">Regulatory Information</a></li> <li class="lcds-primary-nav__list-item"><a href="/safety">Safety</a></li> <li class="lcds-primary-nav__list-item"><a href="/emergency-preparedness-and-response">Emergency Preparedness</a></li> <li class="lcds-primary-nav__list-item"><a href="/international-programs">International Programs</a></li> <li class="lcds-primary-nav__list-item"><a href="/news-events">News and Events</a></li> <li class="lcds-primary-nav__list-item"><a href="/training-and-continuing-education">Training and Continuing Education</a></li> <li class="lcds-primary-nav__list-item"><a href="/inspections-compliance-enforcement-and-criminal-investigations">Inspections and Compliance</a></li> <li class="lcds-primary-nav__list-item"><a href="/science-research">Science and Research</a></li> </ul> </section> <section class="lcds-primary-nav__group lcds-primary-nav__group--bordered"> <h2 class="lcds-primary-nav__group-heading">Information For</h2> <ul class="lcds-primary-nav__list"> <li class="lcds-primary-nav__list-item"><a href="/consumers">Consumers</a></li> <li class="lcds-primary-nav__list-item"><a href="/patients">Patients</a></li> <li class="lcds-primary-nav__list-item"><a href="/industry">Industry</a></li> <li class="lcds-primary-nav__list-item"><a href="/health-professionals">Health Professionals</a></li> <li class="lcds-primary-nav__list-item"><a href="/federal-state-local-tribal-and-territorial-officials">Federal, State and Local Officials</a></li> </ul> </section> </div> </nav> </header> <div class="col-xs-12"> <div data-drupal-messages-fallback class="hidden"></div> </div> <section id="block-entityviewcontent" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <a class="lcds-button--expandable collapsed hidden-md hidden-lg" data-toggle="collapse" href="#section-nav" >In this section<span class="visible-sm-inline-block">: Coronavirus (COVID-19) and Medical Devices </span> </a> <nav id="section-nav" class="lcds-card lcds-section-nav lcds-section-nav hidden-md hidden-lg collapse"> <ul class="lcds-section-nav__list"> <li> <a href="/medical-devices/emergency-situations-medical-devices/coronavirus-covid-19-and-medical-devices" title="Coronavirus (COVID-19) and Medical Devices" class="lcds-section-nav__section-link lcds-section-nav__link lcds-section-nav__parent-link visible-xs-block visible-sm-block"> Coronavirus (COVID-19) and Medical Devices </a> <div class="views-element-container form-group"><div class="view view-in-this-section view-id-in_this_section view-display-id-block_5 js-view-dom-id-c22e3908c78a9e12d605e5852353215b7130de4918da6235c82ea2f984b4dd59"> <div> <ul class="lcds-section-nav__section-link__active lcds-section-nav__list"> <li><a href="/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests" class="lcds-section-nav__link">At-Home OTC COVID-19 Diagnostic Tests</a></li> <li><a href="/medical-devices/coronavirus-covid-19-and-medical-devices/counterfeit-home-otc-covid-19-diagnostic-tests" class="lcds-section-nav__link">Counterfeit At-Home OTC COVID-19 Diagnostic Tests</a></li> <li><a href="/medical-devices/coronavirus-covid-19-and-medical-devices/home-covid-19-diagnostic-tests-frequently-asked-questions" class="lcds-section-nav__link">At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions</a></li> <li><a href="/medical-devices/coronavirus-covid-19-and-medical-devices/antibody-serology-testing-covid-19-information-patients-and-consumers" class="lcds-section-nav__link">Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers</a></li> <li><a href="/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-tests-granted-traditional-marketing-authorization-fda" class="lcds-section-nav__link">COVID-19 Tests Granted Traditional Marketing Authorization by the FDA</a></li> <li><a href="/medical-devices/coronavirus-covid-19-and-medical-devices/face-masks-barrier-face-coverings-surgical-masks-and-respirators-covid-19" class="lcds-section-nav__link">Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19</a></li> <li><a href="/medical-devices/coronavirus-covid-19-and-medical-devices/adverse-event-reporting-medical-devices-under-emergency-use-authorization-eua" class="lcds-section-nav__link">Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA)</a></li> <li><a href="/medical-devices/coronavirus-covid-19-and-medical-devices/contacts-medical-devices-related-covid-19" class="lcds-section-nav__link">Contacts for Medical Devices Related to COVID-19</a></li> </ul> </div> </div> </div> <div class="views-element-container form-group"><div class="view view-in-this-section-sub view-id-in_this_section_sub view-display-id-block_2 js-view-dom-id-8cbdfbcaf553303bbd743025a0f6d9bc42865837b87a07ac966b78eb6b89800e"> </div> </div> </li> </ul> </nav> </section> <section id="block-entityviewcontent-15" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <ol class="lcds-breadcrumb visible-md visible-lg"> <li > <a href="/">Home</a> </li> <li > <a href="/medical-devices">Medical Devices</a> </li> <li > <a href="/medical-devices/medical-device-safety">Medical Device Safety</a> </li> <li > <a href="/medical-devices/medical-device-safety/emergency-situations-medical-devices">Emergency Situations (Medical Devices)</a> </li> <li > <a href="/medical-devices/emergency-situations-medical-devices/coronavirus-covid-19-and-medical-devices">Coronavirus (COVID-19) and Medical Devices</a> </li> <li > <a class="current-link">At-Home OTC COVID-19 Diagnostic Tests</a> </li> </ol> <ol class="lcds-breadcrumb visible-sm visible-xs"> <li> <a href="/medical-devices/emergency-situations-medical-devices/coronavirus-covid-19-and-medical-devices" title="Coronavirus (COVID-19) and Medical Devices"> Coronavirus (COVID-19) and Medical Devices </a> </li> </ol> </section> <main> <article id="main-content" class="article main-content container-fluid" role="article"> <header class="row content-header" role="heading" aria-level="1"> <section id="block-entityviewcontent-2" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <h1 class="content-title text-center">At-Home OTC COVID-19 Diagnostic Tests</h1> <div class="lcds-toolbar lcds-toolbar--social"> <a href="#subscribe" class="btn btn-sm btn-default header-button-subscribe">Subscribe to Email Updates</a> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Fmedical-devices%2Fcoronavirus-covid-19-and-medical-devices%2Fhome-otc-covid-19-diagnostic-tests" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a href="https://x.com/intent/tweet/?text=At-Home%20OTC%20COVID-19%20Diagnostic%20Tests&url=https://www.fda.gov%2Fmedical-devices%2Fcoronavirus-covid-19-and-medical-devices%2Fhome-otc-covid-19-diagnostic-tests" target="_blank" class="lcds-share__btn lcds-share--default__btn-x-twitter js-share" id="twitter-share"> <svg class="icon-svg-inline" aria-hidden="true"> <use href="/themes/custom/preview/assets/images/fa-icons.svg#icon-x-twitter"> </svg> Post </a> </li> <li class="lcds-share__item hidden-xs"> <a href="https://www.linkedin.com/shareArticle?mini=true&url=https://www.fda.gov%2Fmedical-devices%2Fcoronavirus-covid-19-and-medical-devices%2Fhome-otc-covid-19-diagnostic-tests&title=At-Home%20OTC%20COVID-19%20Diagnostic%20Tests&source=FDA" class="lcds-share__btn lcds-share--default__btn-linkedin js-share" id="linkedin-share" target="_blank"><span class="fa icon-linkedin" aria-hidden="true"></span>Linkedin</a> </li> <li class="lcds-share__item"> <a href="mailto:?subject=At-Home%20OTC%20COVID-19%20Diagnostic%20Tests&body=https://www.fda.gov%2Fmedical-devices%2Fcoronavirus-covid-19-and-medical-devices%2Fhome-otc-covid-19-diagnostic-tests" class="lcds-share__btn lcds-share--default__btn-mail"><span class="fa icon-envelope" aria-hidden="true"></span>Email</a> </li> <li class=" lcds-share__item hidden-xs"> <a href="javascript:window.print();" title="Print this page" class="lcds-share__btn lcds-share--default__btn-print"><span class="fa icon-print" aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <p><a class="btn btn-default" data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="4935ed37-b91a-427c-8792-d1ce8963657a" href="/medical-devices/coronavirus-covid-19-and-medical-devices/pruebas-de-covid-19-sin-receta-medica-o-de-venta-libre-para-diagnostico-en-el-hogar" title="Pruebas de COVID-19 sin receta médica o de venta libre para diagnóstico en el hogar"><span title="Español"><span class="text">Español</span></span></a></p> <div class="callout"> <p>Now available, U.S. households are eligible to order 4 free COVID-19 tests at <a href="https://www.covidtests.gov/">www.COVIDTests.gov</a>. The COVID-19 tests will detect current COVID-19 variants and can be used through the end of the year.</p> <p>Many COVID-19 tests have extended expiration dates, so you may be able to use your COVID-19 tests after the expiration date that is printed on the box. To find out if your test has an extended expiration date, check the <a href="https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests#list">list of extended expiration dates</a>.</p> </div> <h2>On this page:</h2> <ul> <li><a href="#general">General Information About At-Home OTC COVID-19 Diagnostic Tests</a></li> <li><a href="#list">Authorized At-Home OTC COVID-19 Diagnostic Tests and Expiration Dates</a></li> <li><a href="#Related">Related Information</a></li> </ul> <hr> <h2><a name="general"></a>General Information About At-Home OTC COVID-19 Diagnostic Tests</h2> <div alt="A woman performing a nose swab on herself as part of a COVID at home test." data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="Array" data-entity-type="media" data-entity-uuid="44c10e4d-35bc-4e47-b0eb-348d8100aae3" data-langcode="en" title="A woman performing a nose swab on herself as part of a COVID at home test." class="align-right embedded-entity"> <img loading="lazy" src="/files/at-home-covid-test.jpg" alt="A woman performing a nose swab on herself as part of a COVID at home test." title="A woman performing a nose swab on herself as part of a COVID at home test." class="img-responsive"> </div> <p>At-home over-the-counter (OTC) COVID-19 diagnostic tests can show if you have an active COVID-19 infection.</p> <p>These at-home OTC COVID-19 diagnostic tests are <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="16d8d1b0-6593-4914-941d-26b0225c5d0c" href="/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization" title="Emergency Use Authorization">FDA authorized</a> for self-testing at home (or in other locations) without a prescription. Tests are available online or at local stores and  you collect your own sample, perform the test, and read the result yourself without the need to send a sample to a laboratory.</p> <p>With most at-home OTC COVID-19 diagnostic tests, you should repeat testing following a negative result, whether you have symptoms or not, to reduce your risk of a false negative test result. The FDA encourages you to voluntarily and anonymously report your positive or negative test results every time you use an at-home COVID-19 test. You can send your test result to <a href="http://www.MakeMyTestCount.org">MakeMyTestCount.org</a> or use an app or other digital option for self-reporting that may be included with your test. For additional information on reading and understanding your test results, see <strong><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="34e8b0ff-b511-42b1-a25f-43f676a45a3f" href="/medical-devices/coronavirus-covid-19-and-medical-devices/understanding-home-otc-covid-19-antigen-diagnostic-test-results" title="Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results">Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results</a></strong>.</p> <p>For more information, including answers to frequently asked general questions about at-home COVID-19 diagnostic tests, visit <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="1d2b7568-07ab-4083-ab7b-25359f60533f" href="/medical-devices/coronavirus-covid-19-and-medical-devices/home-covid-19-diagnostic-tests-frequently-asked-questions" title="At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions">At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions</a>.</p> <h2><a name="list"></a>Authorized At-Home OTC COVID-19 Diagnostic Tests and Expiration Dates</h2> <p>The table below is updated regularly and lists FDA-authorized at-home OTC COVID-19 diagnostic tests, including information on expiration dates, who can use the test, links to home use instructions for each test, and other details that may help you decide what test is right for you. For additional information about each Emergency Use Authorization (EUA), see <strong><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="35fea712-9223-4b11-bd80-4b0418024946" href="/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas" title="In Vitro Diagnostics EUAs">In Vitro Diagnostics EUAs: Tables of IVD EUAs</a></strong>.</p> <p>In the table below, the "Expiration Date" column lists where to find the expiration date for that test, and the "Other Details" column lists the shelf-life for the test. The <strong>shelf-life</strong> is how long the test should work as expected and is measured from the date the test was manufactured. The <strong>expiration date</strong> is set at the end of the shelf-life and is the date through which the test is expected to perform as accurately as when manufactured. In some cases, the expiration date for a test may be extended.</p> <p>An extended expiration date means the manufacturer provided data showing that the shelf-life is longer than was known when the test was first authorized. For more information about how the expiration date is determined and why it may be extended, see the <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="1d2b7568-07ab-4083-ab7b-25359f60533f" href="/medical-devices/coronavirus-covid-19-and-medical-devices/home-covid-19-diagnostic-tests-frequently-asked-questions" title="At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions">At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions</a>.   </p> <p>To see if the expiration date for your at-home OTC COVID-19 test has been extended, first find the row in the below table that matches the manufacturer and test name shown on the box label of your test. If the expiration date has been extended, then the Expiration Date column states "<strong>Extended Expiration Date</strong>" and links to a document that lists the lot numbers, original expiration dates, and the extended expiration dates. If your lot number and/or original expiration date do not appear, or if the Expiration Date column states “Expiration Date: See box label,” do not use the test beyond the original expiration date on your test. </p> <p>Search the table below by manufacturer, test name, or other details shown in the table to find more information on the test, including if the expiration date has been extended. </p> <p>To see complete information on smaller screens, select the blue plus (+) button beside the test name.</p> <div class="lcds-datatable lcds-datatable--ckeditor"> <table aria-readonly="true" class="table" data-column-defs="[{ "targets": 1, "type": "date" }]" data-order="[ 0, "asc" ]" data-page-length="50" data-paging="true" data-searching="true" role="grid" summary="List of Authorized At-Home OTC COVID-19 Diagnostic Tests"> <thead> <tr> <th><strong>Manufacturer and Test Name (Links to Instructions for Use)</strong></th> <th>Expiration Date</th> <th><strong>Who can use this test: Symptoms</strong></th> <th><strong>Who can use this test: Age</strong></th> <th><strong>Other Details</strong></th> </tr> </thead> <tbody> <tr> <td> <p>Abbott Diagnostics Scarborough, Inc.:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="3436d6ba-8770-4262-8d85-defebb2d63de" href="/media/144575/download?attachment" title="BinaxNOW COVID-19 Ag Card Home Test - Instructions for Use (Home Test)">BinaxNOW COVID-19 Ag Card Home Test</a></p> <a href="/media/160087/download"> <div alt="Packaging for Abbott Diagnostics Scarborough, Inc.: BinaxNOW COVID-19 Ag Card Home Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="square_1_1_112_x_112" data-entity-type="media" data-entity-uuid="a482beeb-a56a-4e67-91fd-f09fd38865d2" data-langcode="en" title="Packaging for Abbott Diagnostics Scarborough, Inc.: BinaxNOW COVID-19 Ag Card Home Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/square_1_1_112_x_112/public/COVID19-AtHomeTest-Picture1.jpg?itok=daNhTBYF" alt="Packaging for Abbott Diagnostics Scarborough, Inc.: BinaxNOW COVID-19 Ag Card Home Test" title="Packaging for Abbott Diagnostics Scarborough, Inc.: BinaxNOW COVID-19 Ag Card Home Test" class="img-responsive"> </div> </a></td> <td> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="7509fd30-5376-4334-ac14-5cefca05c30e" href="/media/158002/download?attachment" title="BinaxNOW COVID-19 Ag Card Home Test (12 to 15 month extension)">Extended Expiration Date</a></li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 15 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Requires supervision of a telehealth proctor and a smartphone or computer</li> <li>Results in 15 minutes</li> <li>Shelf Life: 22 months</li> </ul> </td> </tr> <tr> <td> <p>Abbott Diagnostics Scarborough, Inc.:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="a1d24e5e-a4dd-450f-9c88-c7b5c7a0eb05" href="/media/147255/download?attachment" title="BinaxNOW COVID-19 Antigen Self Test - IFU (Home Test)">BinaxNOW COVID-19 Antigen Self Test</a></p> <a href="/media/160094/download"> <div alt="Packaging for Abbott Diagnostics Scarborough, Inc.: BinaxNOW COVID-19 Antigen Self Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="square_1_1_112_x_112" data-entity-type="media" data-entity-uuid="6070600d-fc9b-43d2-b3a1-dd4c178c6d49" data-langcode="en" title="Packaging for Abbott Diagnostics Scarborough, Inc.: BinaxNOW COVID-19 Antigen Self Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/square_1_1_112_x_112/public/COVID19-AtHomeTest-Picture2.jpg?itok=RHdHTbBu" alt="Packaging for Abbott Diagnostics Scarborough, Inc.: BinaxNOW COVID-19 Antigen Self Test" title="Packaging for Abbott Diagnostics Scarborough, Inc.: BinaxNOW COVID-19 Antigen Self Test" class="img-responsive"> </div> </a></td> <td> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="c4457554-99c1-4155-8d68-fef4e6554ce1" href="/media/158003/download?attachment" title="BinaxNOW COVID-19 Ag Self Test (15 to 22 month extension)">Extended Expiration Date</a></li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 15 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 15 minutes</li> <li>Shelf Life: 22 months</li> </ul> </td> </tr> <tr> <td> <p>Access Bio, Inc.:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="05158253-2795-414c-9e7f-ec6bb1f1936f" href="/media/152188/download?attachment" title="EUA Accessbio Aghome Instruction for Use Home Test">CareStart COVID-19 Antigen Home Test</a></p> <a href="/media/160095/download"> <div alt="Packaging for Access Bio, Inc.: CareStart COVID-19 Antigen Home Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="square_1_1_112_x_112" data-entity-type="media" data-entity-uuid="8154da00-8af1-4f7d-9759-16971a96b8c5" data-langcode="en" title="Packaging for Access Bio, Inc.: CareStart COVID-19 Antigen Home Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/square_1_1_112_x_112/public/COVID19-AtHomeTest-Picture3.jpg?itok=yHeLz9B3" alt="Packaging for Access Bio, Inc.: CareStart COVID-19 Antigen Home Test" title="Packaging for Access Bio, Inc.: CareStart COVID-19 Antigen Home Test" class="img-responsive"> </div> </a> <p>Alternate brand name:</p> <a href="/media/160097/download"> <div alt="Packaging for On/go COVID-19 Antigen Self-Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="square_1_1_112_x_112" data-entity-type="media" data-entity-uuid="128421cd-ff18-40fe-bdf8-d351f33254ab" data-langcode="en" title="Packaging for On/go COVID-19 Antigen Self-Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/square_1_1_112_x_112/public/COVID19-AtHomeTest-Picture25.jpg?itok=Iu_JlqJX" alt="Packaging for On/go COVID-19 Antigen Self-Test" title="Packaging for On/go COVID-19 Antigen Self-Test" class="img-responsive"> </div> </a></td> <td> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d74cc14b-f53f-42d5-9770-06a57face25b" href="/media/158734/download?attachment" title="Access Bio, Inc.: CareStart COVID-19 Antigen Home Test shelf-life extension">Extended Expiration Date</a></li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 7 days</li> <li>People without symptoms. The test is to be performed two times over three days (serial testing)</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Smartphone optional</li> <li>Alternate brand name: On/go COVID-19 Antigen Self-Test</li> <li>Results in 10 minutes</li> <li>Shelf Life: 21 months</li> </ul> </td> </tr> <tr> <td> <p>ACON Laboratories, Inc:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="8510921f-1737-49ab-8513-80ed3479590f" href="/media/152699/download?attachment" title="ACONlab Flow Flex AG Instruction for Use for Home Test">Flowflex COVID-19 Antigen Home Test</a></p> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="f58edc36-55a3-4ebe-b69f-31735206e17c" href="/media/160099/download?attachment" title="Packaging for ACON Laboratories, Inc: Flowflex COVID-19 Antigen Home Test"> <div alt="Packaging for ACON Laboratories, Inc: Flowflex COVID-19 Antigen Home Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="square_1_1_112_x_112" data-entity-type="media" data-entity-uuid="f58edc36-55a3-4ebe-b69f-31735206e17c" data-langcode="en" title="Packaging for ACON Laboratories, Inc: Flowflex COVID-19 Antigen Home Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/square_1_1_112_x_112/public/COVID19-AtHomeTest-Picture4.jpg?itok=X2YN1rh-" alt="Packaging for ACON Laboratories, Inc: Flowflex COVID-19 Antigen Home Test" title="Packaging for ACON Laboratories, Inc: Flowflex COVID-19 Antigen Home Test" class="img-responsive"> </div> </a> <p>Alternate brand name:</p> <a href="/media/160098/download"> <div alt="Packaging for On/Go One COVID-19 Antigen Home Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="square_1_1_112_x_112" data-entity-type="media" data-entity-uuid="3ab21b74-87d9-45e8-b270-2f21e7565a8b" data-langcode="en" title="Packaging for On/Go One COVID-19 Antigen Home Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/square_1_1_112_x_112/public/COVID19-AtHomeTest-Picture5.jpg?itok=IofAjlaP" alt="Packaging for On/Go One COVID-19 Antigen Home Test" title="Packaging for On/Go One COVID-19 Antigen Home Test" class="img-responsive"> </div> </a></td> <td> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="9b8af044-d75e-41d5-b31a-0ad2183bca80" href="/media/158005/download?attachment" title="Flowflex COVID-19 Antigen Home Test (12 to 16 month extension)">Extended Expiration Date</a></li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 7 days</li> <li>People without symptoms. The test is to be performed two times over three days (serial testing)</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Smartphone optional</li> <li>Alternate brand name: On/Go One COVID-19 Antigen Home Test</li> <li>Results in 15 minutes</li> <li>Shelf Life: 24 months</li> </ul> </td> </tr> <tr> <td> <p>Aptitude Medical Systems Inc.:<br> <a href="/media/162404/download">Metrix COVID-19 Test</a></p> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="e806d314-bb4a-4dfb-a2cc-ea963a74d1f4" href="/media/162438/download?attachment" title="Aptitude Medical Systems Inc.: Metrix COVID-19 Test packaging"> <div alt="Aptitude Medical Systems Inc.: Metrix COVID-19 Test package thumbnail" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-type="media" data-entity-uuid="b6bf3c69-a1e1-4f2d-b20f-8bf7bf7eaffe" data-langcode="en" title="Aptitude Medical Systems Inc.: Metrix COVID-19 Test package thumbnail" class="embedded-entity"> <img loading="lazy" src="/files/Metrix-Covid19-test-th.jpg" alt="Aptitude Medical Systems Inc.: Metrix COVID-19 Test package thumbnail" title="Aptitude Medical Systems Inc.: Metrix COVID-19 Test package thumbnail" class="img-responsive"> </div> </a></td> <td> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ccb8517d-8076-4103-98f3-bfbdfeabd13a" href="/media/177834/download?attachment" title="Aptitude Metrix COVID-19 Test Extended Expirations Date">Extended Expiration Date</a></li> </ul> </td> <td> <ul> <li>People with or without symptoms</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Molecular test</li> <li>Nasal swab</li> <li>Saliva</li> <li>Requires a Metrix Reader (sold separately)</li> <li>Smartphone optional</li> <li>Results in 30 minutes</li> <li>Shelf Life: 18 Months</li> </ul> </td> </tr> <tr> <td> <p>CorDx, Inc.<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d85472cf-f64c-464e-99fe-92f2b06737a2" href="/media/177668/download?attachment" title="CorDx TyFast Flu A/B & COVID-19 Instructions for Use Home Test">CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test</a></p> <div alt="Box for CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="landscape_16_9_400_x_225 Array" data-entity-type="media" data-entity-uuid="8fe4e8af-3596-41c9-9174-3e499a5b3d29" data-langcode="en" title="Box for CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/landscape_16_9_400_x_225/public/EUA_CorDX_test_watermark.jpg?itok=9nXGX7kR" alt="Box for CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test" title="Box for CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test" class="img-responsive"> </div> </td> <td> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="e3412bf5-393b-439d-9163-a18a93a9c664" href="/media/179413/download?attachment" title="CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test 12 to 15 Month extension">Extended Expiration Date</a></li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult </li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 10 minutes</li> <li>Shelf Life: 15 months</li> </ul> </td> </tr> <tr> <td> <p>CTK Biotech, Inc.: <br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="92e43fa9-4286-4b3c-8f1a-30d9a7224284" href="/media/164140/download?attachment" title="ImmuView COVID-19 Antigen Home Test - Instructions for Use (Home Test)">ImmuView COVID-19 Antigen Home Test</a></p> <div alt="ImmuView COVID-19 Antigen Home Test - Instructions for Use (Home Test)" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="landscape_16_9_200_x_112" data-entity-type="media" data-entity-uuid="9300f1a5-9acf-4452-8380-562e96051107" data-langcode="en" title="ImmuView COVID-19 Antigen Home Test - Instructions for Use (Home Test)" class="embedded-entity"> <img loading="lazy" src="/files/styles/landscape_16_9_200_x_112/public/CTKBio_ImmuViewOTC_test%20watermark.jpg?itok=mZLJsfsS" alt="ImmuView COVID-19 Antigen Home Test - Instructions for Use (Home Test)" title="ImmuView COVID-19 Antigen Home Test - Instructions for Use (Home Test)" class="img-responsive"> </div> </td> <td> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="0f9b8c9d-7b59-491d-80c3-0713eed3db48" href="/media/178610/download?attachment" title="ImmuView COVID-19 Antigen Home Test 12-20 Month Extension Dates">Extended Expiration Date</a></li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 15-30 minutes</li> <li>Shelf Life: 20 months</li> </ul> </td> </tr> <tr> <td> <p>Ellume Limited:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="7e86ae3b-4bbf-415a-b1a5-bd6730ee5d46" href="/media/144593/download?attachment" title="Ellume COVID-19 Home Test - Instructions for Use (Home Test)">Ellume COVID-19 Home Test</a></p> <a href="/media/160104/download"> <div alt="Packaging for Ellume Limited: Ellume COVID-19 Home Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="square_1_1_112_x_112" data-entity-type="media" data-entity-uuid="d72662cf-5129-482d-9f99-6887bf03b43b" data-langcode="en" title="Packaging for Ellume Limited: Ellume COVID-19 Home Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/square_1_1_112_x_112/public/COVID19-AtHomeTest-Picture11.jpg?itok=6-1fBouF" alt="Packaging for Ellume Limited: Ellume COVID-19 Home Test" title="Packaging for Ellume Limited: Ellume COVID-19 Home Test" class="img-responsive"> </div> </a></td> <td> <ul> <li>Expiration Date: See box label</li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 4 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 16 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Mid-turbinate nasal swab</li> <li>Requires a Smartphone</li> <li>Results in 15 minutes</li> <li>Shelf Life: 12 months</li> </ul> </td> </tr> <tr> <td> <p>Genabio Diagnostics Inc.:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="c02ff3b1-33b4-458d-9d18-050ff7427186" href="/media/159834/download?attachment" title="Genabio COVID-19 Rapid Self-Test Kit - Instructions for Use (Home Test)">Genabio COVID-19 Rapid Self-Test Kit</a></p> <a href="/media/160105/download"> <div alt="Packaging for Genabio Diagnostics Inc.: Genabio COVID-19 Rapid Self-Test Kit" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="square_1_1_112_x_112" data-entity-type="media" data-entity-uuid="42436a54-d787-41a5-ac53-01605e327b09" data-langcode="en" title="Packaging for Genabio Diagnostics Inc.: Genabio COVID-19 Rapid Self-Test Kit" class="embedded-entity"> <img loading="lazy" src="/files/styles/square_1_1_112_x_112/public/COVID19-AtHomeTest-Picture12.jpg?itok=KfUVMvVd" alt="Packaging for Genabio Diagnostics Inc.: Genabio COVID-19 Rapid Self-Test Kit" title="Packaging for Genabio Diagnostics Inc.: Genabio COVID-19 Rapid Self-Test Kit" class="img-responsive"> </div> </a></td> <td> <ul> <li>Expiration Date: See box label</li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 7 days.</li> <li>People without symptoms. The test is to be performed two times over three days (serial testing)</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 15-30 minutes</li> <li>Shelf Life: 18 months</li> </ul> </td> </tr> <tr> <td> <p>iHealth Labs, Inc.:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="bc66a9b1-497d-4c8c-924e-83928176f707" href="/media/153924/download?attachment" title="iHealth Rapid TestAg Instructions for Use Home Test">iHealth COVID-19 Antigen Rapid Test</a></p> <a href="/media/160107/download"> <div alt="Packaging for iHealth Labs, Inc.: iHealth COVID-19 Antigen Rapid Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="square_1_1_112_x_112" data-entity-type="media" data-entity-uuid="ea161ad7-f4ab-4f5c-8914-6adb2bf6c0cf" data-langcode="en" title="Packaging for iHealth Labs, Inc.: iHealth COVID-19 Antigen Rapid Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/square_1_1_112_x_112/public/COVID19-AtHomeTest-Picture13.jpg?itok=k9xgM9LS" alt="Packaging for iHealth Labs, Inc.: iHealth COVID-19 Antigen Rapid Test" title="Packaging for iHealth Labs, Inc.: iHealth COVID-19 Antigen Rapid Test" class="img-responsive"> </div> </a> <p>Alternate brand name:</p> <a href="/media/160106/download"> <div alt="Packaging for GoodToKnow COVID-19 Antigen Rapid Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="square_1_1_112_x_112" data-entity-type="media" data-entity-uuid="9c96cecc-79b8-4e89-a4b1-78b2fa70e8d7" data-langcode="en" title="Packaging for GoodToKnow COVID-19 Antigen Rapid Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/square_1_1_112_x_112/public/COVID19-AtHomeTest-Picture10.jpg?itok=ASPX6d0q" alt="Packaging for GoodToKnow COVID-19 Antigen Rapid Test" title="Packaging for GoodToKnow COVID-19 Antigen Rapid Test" class="img-responsive"> </div> </a></td> <td> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="7dca5e35-1257-40b7-bdf6-7dd0b842061f" href="/media/164551/download?attachment" title="iHealth COVID-19 Antigen Rapid Test (12-to-15-month extension)">Extended Expiration Date</a></li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 15 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Smartphone optional</li> <li>Results in 15 minutes</li> <li>Alternate brand name: GoodToKnow COVID-19 Antigen Rapid Test</li> <li>Alternate brand name: GoToKnow COVID-19 Antigen Rapid Test</li> <li>Shelf Life: 15 months</li> </ul> </td> </tr> <tr> <td> <p>InBios International Inc:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="c5abd8ca-7eb3-495d-b662-7649931461d5" href="/media/154337/download?attachment" title="SCoV-2 Ag Detect Rapid Self-Test - Instructions for Use (Home Test)">SCoV-2 Ag Detect Rapid Self-Test</a></p> <a href="/media/160108/download"> <div alt="Packaging for InBios International Inc: SCoV-2 Ag Detect Rapid Self-Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="square_1_1_112_x_112" data-entity-type="media" data-entity-uuid="8145734e-b14f-4e67-9c3f-61b3610c7b38" data-langcode="en" title="Packaging for InBios International Inc: SCoV-2 Ag Detect Rapid Self-Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/square_1_1_112_x_112/public/COVID19-AtHomeTest-Picture14.jpg?itok=rovxTsed" alt="Packaging for InBios International Inc: SCoV-2 Ag Detect Rapid Self-Test" title="Packaging for InBios International Inc: SCoV-2 Ag Detect Rapid Self-Test" class="img-responsive"> </div> </a></td> <td> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d81ce16b-26e2-472d-ab4a-82022333fb1a" href="/media/158008/download?attachment" title="SCoV-2 Ag Detect Rapid Self-Test (10 to 13 month extension)">Extended Expiration Date</a></li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 20 minutes</li> <li>Shelf Life: 13 months</li> </ul> </td> </tr> <tr> <td> <p>Immunostics Inc.:<a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="338cebac-4da7-4e56-8da6-d71c16f20c6e" href="/media/170420/download?attachment" title="EUA Immunostics Swab-N-GoOTC IFU Home Test"> Swab-N-Go Home Test COVID-19 Ag </a></p> <div alt="Box Label: Immunostics Inc.: Swab-N-Go Home Test COVID-19 Ag " data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="landscape_16_9_200_x_112 Array" data-entity-type="media" data-entity-uuid="766d9df8-ab20-49e5-8752-bc7afb29f9e2" data-langcode="en" title="Box Label: Immunostics Inc.: Swab-N-Go Home Test COVID-19 Ag " class="embedded-entity"> <img loading="lazy" src="/files/styles/landscape_16_9_200_x_112/public/EUA-Immunostics-Swab-N-GoOTC_BoxLabel.jpg?itok=wMzfybPS" alt="Box Label: Immunostics Inc.: Swab-N-Go Home Test COVID-19 Ag " title="Box Label: Immunostics Inc.: Swab-N-Go Home Test COVID-19 Ag " class="img-responsive"> </div> </td> <td> <ul> <li>Expiration Date: See box label </li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 15-30 minutes </li> <li>Shelf Life: 20 months </li> </ul> </td> </tr> <tr> <td> <p>Pfizer Inc:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="faf1f324-3aa2-45db-98d1-f47603b75913" href="/media/147495/download?attachment" title="Pfizer CHECK-IT COVID-19 Test Kit - IFU (Home Test)">Lucira CHECK-IT COVID-19 Test Kit</a></p> <div alt="Pfizer Check Box Label" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="square_1_1_112_x_112 Array" data-entity-type="media" data-entity-uuid="26d85844-1f7b-4829-b4ef-d575157c5ca9" data-langcode="en" title="Packaging for Pfizer CHECK-IT COVID-19 Test Kit" class="embedded-entity"> <img loading="lazy" src="/files/styles/square_1_1_112_x_112/public/EUA-Pfizer-check-BoxLabel.jpg?itok=EuESvDRY" alt="Pfizer Check Box Label" title="Packaging for Pfizer CHECK-IT COVID-19 Test Kit" class="img-responsive"> </div> </td> <td> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="783a34c9-87e3-41ba-9480-9fba044ec9c9" href="/media/161056/download?attachment" title="Extended Expiration Date for Lucira CHECK-IT COVID-19 Test Kit">Extended Expiration Date</a></li> </ul> </td> <td> <ul> <li>People with or without symptoms</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Molecular test</li> <li>Nasal swab</li> <li>Smartphone optional</li> <li>Results in 30 minutes</li> <li>Shelf Life: 18 months</li> </ul> </td> </tr> <tr> <td> <p>Maxim Biomedical, Inc.:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="abee1b04-2cf7-42c8-945c-7e65e3410c9e" href="/media/155635/download?attachment" title="ClearDetect COVID-19 Antigen Home Test - IFU (Home Test)">MaximBio ClearDetect COVID-19 Antigen Home Test</a></p> <a href="/media/160110/download"> <div alt="Packaging for Maxim Biomedical, Inc.: MaximBio ClearDetect COVID-19 Antigen Home Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="square_1_1_112_x_112" data-entity-type="media" data-entity-uuid="685f4fb6-074d-4759-ae4a-98de6d6f4d55" data-langcode="en" title="Packaging for Maxim Biomedical, Inc.: MaximBio ClearDetect COVID-19 Antigen Home Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/square_1_1_112_x_112/public/COVID19-AtHomeTest-Picture16.jpg?itok=JsglZbkR" alt="Packaging for Maxim Biomedical, Inc.: MaximBio ClearDetect COVID-19 Antigen Home Test" title="Packaging for Maxim Biomedical, Inc.: MaximBio ClearDetect COVID-19 Antigen Home Test" class="img-responsive"> </div> </a></td> <td> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="7c5c7231-7e35-41cc-b5a3-b33960e51fad" href="/media/160581/download?attachment" title="Extended Expiration Date for MaximBio ClearDetect COVID-19 Antigen Home Tests">Extended Expiration Date</a></li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 15 minutes</li> <li>Shelf Life: 24 months</li> </ul> </td> </tr> <tr> <td> <p>Mologic, Inc.:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="a81dab06-f9bc-4a7f-a111-80d3fabbafc4" href="/media/165584/download?attachment" title="COVI-Go SARS-CoV-2 Ag Self-Test - Instructions for Use (Home Test)">COVI-Go SARS-CoV-2 Ag Self-Test</a></p> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="769023e9-bdd8-4c87-a737-91f285aaba66" href="/media/165588/download?attachment" title="Mologic, Inc.: COVI-Go SARS-CoV-2 Ag Self-Test Box Label"> <div alt="Mologic, Inc.: COVI-Go SARS-CoV-2 Ag Self-Test Box Label" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="square_1_1_112_x_112 Array" data-entity-type="media" data-entity-uuid="769023e9-bdd8-4c87-a737-91f285aaba66" data-langcode="en" title="Mologic, Inc.: COVI-Go SARS-CoV-2 Ag Self-Test Box Label" class="embedded-entity"> <img loading="lazy" src="/files/styles/square_1_1_112_x_112/public/Mologic-COVI-GoOTC_BoxLabel.jpg?itok=4XYAtfch" alt="Mologic, Inc.: COVI-Go SARS-CoV-2 Ag Self-Test Box Label" title="Mologic, Inc.: COVI-Go SARS-CoV-2 Ag Self-Test Box Label" class="img-responsive"> </div> </a></td> <td> <ul> <li>Expiration Date: See box label</li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 20 minutes</li> <li>Shelf Life: 6 months</li> </ul> </td> </tr> <tr> <td> <p>OraSure Technologies, Inc.:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="9f4508d1-3ed9-46fa-8e86-8b98d312074a" href="/media/149912/download?attachment" title="InteliSwab COVID-19 Rapid Test - Instructions for Use (Home Test)">InteliSwab COVID-19 Rapid Test</a></p> <a href="/media/160111/download"> <div alt="Packaging for OraSure Technologies, Inc.: InteliSwab COVID-19 Rapid Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="square_1_1_112_x_112" data-entity-type="media" data-entity-uuid="17d4b873-a82f-4798-bcb9-4f65387b7c83" data-langcode="en" title="Packaging for OraSure Technologies, Inc.: InteliSwab COVID-19 Rapid Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/square_1_1_112_x_112/public/COVID19-AtHomeTest-Picture17.jpg?itok=NLJOQED8" alt="Packaging for OraSure Technologies, Inc.: InteliSwab COVID-19 Rapid Test" title="Packaging for OraSure Technologies, Inc.: InteliSwab COVID-19 Rapid Test" class="img-responsive"> </div> </a></td> <td> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="413886cc-14b2-4b74-aa95-31b38683d1b8" href="/media/161057/download?attachment" title="Extended Expiration Date for InteliSwab COVID-19 Rapid Test">Extended Expiration Date</a></li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 18 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Smartphone optional</li> <li>Results in 30 minutes</li> <li>Shelf Life: 24 months</li> </ul> </td> </tr> <tr> <td> <p>OSANG LLC:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="cbaca2c0-5fdf-4d84-879e-dd97a8f67db8" href="/media/157549/download?attachment" title="OSANG OHC Ag Test - Instructions for Use Home Test">OHC COVID-19 Antigen Self Test</a></p> <a href="/media/161361/download"> <div alt="OHC COVID-19 Antigen Self Test Packaging" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="square_1_1_112_x_112" data-entity-type="media" data-entity-uuid="f8392fa0-903a-4252-8ef3-159931968fb1" data-langcode="en" title="Packaging for QuickFinder COVID-19 Antigen Self Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/square_1_1_112_x_112/public/osang-covid-19-llc-packaging.png?itok=8fa1_j1j" alt="OHC COVID-19 Antigen Self Test Packaging" title="Packaging for QuickFinder COVID-19 Antigen Self Test" class="img-responsive"> </div> </a> <p>Alternate brand name:</p> <a href="/media/161362/download"> <div alt="Quickfinder Covid-19 Antigen Self Test Packaging" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="square_1_1_112_x_112" data-entity-type="media" data-entity-uuid="dd2e6bd3-248b-49ad-9132-0dd720cf8fce" data-langcode="en" title="Packaging for QuickFinder COVID-19 Antigen Self Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/square_1_1_112_x_112/public/OHC%20QuickFinder%20Covid-19%20Self%20Test%20Box%20Image.jpg?itok=0BgJ0WsW" alt="Quickfinder Covid-19 Antigen Self Test Packaging" title="Packaging for QuickFinder COVID-19 Antigen Self Test" class="img-responsive"> </div> </a></td> <td> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="f2d1dd30-3973-42c3-a008-d1d893e83616" href="/media/161358/download?attachment" title="OSANG OHC COVID-19 Antigen Self Test - Shelf-Life Extension">Extended Expiration Date</a></li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing)</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Alternate brand name: QuickFinder COVID-19 Antigen Self Test</li> <li>Results in 15 minutes</li> <li>Shelf Life: 24 months</li> </ul> </td> </tr> <tr> <td> <p>OSANG LLC:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="644710ad-73c9-4882-b071-38cb86713975" href="/media/177970/download?attachment" title="QuickFinder COVID-19/Flu Antigen Self Test - Instructions for Use (Home Test)">QuickFinder COVID-19/Flu Antigen Self Test</a></p> <div alt="QuickFinder COVID-19/Flu Antigen Self Test Packaging" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="portrait_3_4_112_x_150 Array" data-entity-type="media" data-entity-uuid="d2fb4d1d-98d2-4459-ad66-ec6cd7753963" data-langcode="en" title="QuickFinder COVID-19/Flu Antigen Self Test Packaging" class="embedded-entity"> <img loading="lazy" src="/files/styles/portrait_3_4_112_x_150/public/EUA_Quickfinder_CovidFlu_test_watermark.jpg?itok=W-ZGn6kR" alt="QuickFinder COVID-19/Flu Antigen Self Test Packaging" title="QuickFinder COVID-19/Flu Antigen Self Test Packaging" class="img-responsive"> </div> </td> <td> <ul> <li>See box label</li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 4 days. The test is to be performed two times over three days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult </li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 15 minutes</li> <li>Shelf Life: 18 months</li> </ul> </td> </tr> <tr> <td> <p>PHASE Scientific International, Ltd.:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="3a3f3fbb-d1b4-421a-8e8a-d878d226b825" href="/media/156955/download?attachment" title="PHASE OTCAg - Instructions for Use Home Test">INDICAID COVID-19 Rapid Antigen At-Home Test</a></p> <a href="/media/160113/download"> <div alt="Packaging for PHASE Scientific International, Ltd.: INDICAID COVID-19 Rapid Antigen At-Home Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="square_1_1_112_x_112" data-entity-type="media" data-entity-uuid="fecf3bc1-bdb3-4d63-8123-32012385dadf" data-langcode="en" title="Packaging for PHASE Scientific International, Ltd.: INDICAID COVID-19 Rapid Antigen At-Home Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/square_1_1_112_x_112/public/COVID19-AtHomeTest-Picture19.jpg?itok=bSR1lYlV" alt="Packaging for PHASE Scientific International, Ltd.: INDICAID COVID-19 Rapid Antigen At-Home Test" title="Packaging for PHASE Scientific International, Ltd.: INDICAID COVID-19 Rapid Antigen At-Home Test" class="img-responsive"> </div> </a></td> <td> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="90238774-6ecd-4e2f-9dc6-0ede7792330f" href="/media/169735/download?attachment" title="INDICAID COVID-19 Rapid Antigen At-Home Test (12-to-15-month extension)">Extended Expiration Date</a></li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 20 minutes</li> <li>Shelf Life: 15 months</li> </ul> </td> </tr> <tr> <td> <p>Quidel Corporation:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="e44d0cf5-1692-4b02-bf96-30d1b2494a39" href="/media/147250/download?attachment" title="QuickVue At-Home OTC COVID-19 Test - IFU (Home Test)">QuickVue At-Home OTC COVID-19 Test</a></p> <a href="/media/162058/download"> <div alt="Packaging for Quidel Corporation: QuickVue At-Home OTC COVID-19 Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="portrait_3_4_112_x_150 Array" data-entity-type="media" data-entity-uuid="ca471491-3e80-498f-be7c-9176c21c62fc" data-langcode="en" title="Packaging for Quidel Corporation: QuickVue At-Home OTC COVID-19 Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/portrait_3_4_112_x_150/public/QuickVue-watermark_0.jpg?itok=MvjNr_zO" alt="Packaging for Quidel Corporation: QuickVue At-Home OTC COVID-19 Test" title="Packaging for Quidel Corporation: QuickVue At-Home OTC COVID-19 Test" class="img-responsive"> </div> </a> <p>Alternative Brand Names:</p> <div alt="CVS Health At Home COVID-19 Test Kit " data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="landscape_16_9_200_x_112 Array" data-entity-type="media" data-entity-uuid="49723458-55cc-4869-a081-417196940dfd" data-langcode="en" title="CVS Health At Home COVID-19 Test Kit " class="embedded-entity"> <img loading="lazy" src="/files/styles/landscape_16_9_200_x_112/public/CVS_athomeOTC_BoxLabel.jpg?itok=4_S1vzMx" alt="CVS Health At Home COVID-19 Test Kit " title="CVS Health At Home COVID-19 Test Kit " class="img-responsive"> </div> <p> </p> <div alt="Walgreens At-Home COVID-19 Test Kit" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="landscape_16_9_200_x_112 Array" data-entity-type="media" data-entity-uuid="bb73512f-8ece-4faa-a067-c87effc398de" data-langcode="en" title="Walgreens At-Home COVID-19 Test Kit" class="embedded-entity"> <img loading="lazy" src="/files/styles/landscape_16_9_200_x_112/public/Walgreens_athomeOTC_BoxLabel.jpg?itok=ZmS2YFif" alt="Walgreens At-Home COVID-19 Test Kit" title="Walgreens At-Home COVID-19 Test Kit" class="img-responsive"> </div> </td> <td> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="2699b294-021b-4cc5-bf6e-7a9bbd0a2d33" href="/media/162056/download?attachment" title="Quidel Corporation: QuickVue At-Home OTC COVID-19 Test self-life extension">Extended Expiration Date</a></li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Alternative Brand Names: CVS Health At Home COVID-19 Test Kit and Walgreens At-Home COVID-19 Test Ket</li> <li>Results in 10 minutes</li> <li>Shelf Life: 16 months</li> </ul> </td> </tr> <tr> <td> <p>Watmind USA: <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="35107787-a2da-4953-b25a-693523a83619" href="/media/179356/download?attachment" title="Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test - Instructions for Use (Home Test)">Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test</a></p> <div alt="Box Label of the Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="square_1_1_112_x_112 Array" data-entity-type="media" data-entity-uuid="e08e4d44-d981-404f-a32d-5bbbe2dc89c7" data-langcode="en" title="Box Label of the Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/square_1_1_112_x_112/public/EUA-Watmind-SpeedyOTC-COVID-Flu-BoxLabel.jpg?itok=azHuRy4k" alt="Box Label of the Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test" title="Box Label of the Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test" class="img-responsive"> </div> </td> <td> <ul> <li>Expiration Date: See box label</li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 15 minutes</li> <li>Shelf Life: 18 months</li> </ul> </td> </tr> <tr> <td> <p>SD Biosensor, Inc.:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="5d986b92-b730-459b-93b8-8d4ff83a7d72" href="/media/155126/download?attachment" title="Pilot COVID-19 At-Home Test - Instructions for Use (Home Test)">Pilot COVID-19 At-Home Test <a class="see-footnote" id="footnoteref1_eh5dgqy" title="The Pilot COVID-19 At-Home Test, distributed by Roche Diagnostics, is previously known as the COVID-19 At-Home Test. As the manufacturer, SD Biosensor, transitions to this new brand, customers may receive a product with the previously authorized COVID-19 At-Home Test labeling. " href="#footnote1_eh5dgqy">1</a> </a></p> <a href="/media/160115/download"> <div alt="Packaging for SD Biosensor, Inc.: Pilot COVID-19 At-Home Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="square_1_1_112_x_112" data-entity-type="media" data-entity-uuid="14a5941c-efa8-4b24-aae3-b52b6dcd8b85" data-langcode="en" title="Packaging for SD Biosensor, Inc.: Pilot COVID-19 At-Home Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/square_1_1_112_x_112/public/COVID19-AtHomeTest-Picture21.jpg?itok=EDBL34UX" alt="Packaging for SD Biosensor, Inc.: Pilot COVID-19 At-Home Test" title="Packaging for SD Biosensor, Inc.: Pilot COVID-19 At-Home Test" class="img-responsive"> </div> </a> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="ed14c289-1d32-473a-8051-292843a94fa2" href="/medical-devices/safety-communications/do-not-use-certain-sd-biosensor-pilot-covid-19-home-tests-fda-safety-communication" title="Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests: FDA Safety Communication">FDA Safety Communication - Recall of Certain Lots</a></p> </td> <td> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="50ddcb5c-6d31-4bfc-8536-4e629736485a" href="/media/159640/download?attachment" title="SD Biosensor, Inc.: Pilot COVID-19 At-Home Test Shelf Life Extension">Extended Expiration Date</a></li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 20 minutes</li> <li>Telehealth Proctor Supervised (optional)</li> <li>Shelf Life: 16 months</li> </ul> </td> </tr> <tr> <td> <p>Siemens Healthineers:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="4649051d-b89a-4c6f-9664-ee8d5e26b41a" href="/media/155176/download?attachment" title="CLINITEST Rapid COVID-19 Antigen Self-Test - IFU (Home Test)">CLINITEST Rapid COVID-19 Antigen Self-Test</a></p> <a href="/media/160116/download"> <div alt="Packaging for Siemens Healthineer: CLINITEST Rapid COVID-19 Antigen Self-Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="square_1_1_112_x_112" data-entity-type="media" data-entity-uuid="32f6c832-1617-4cd6-be63-965e4cf07f3c" data-langcode="en" title="Packaging for Siemens Healthineer: CLINITEST Rapid COVID-19 Antigen Self-Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/square_1_1_112_x_112/public/COVID19-AtHomeTest-Picture22.jpg?itok=GbvkekyU" alt="Packaging for Siemens Healthineer: CLINITEST Rapid COVID-19 Antigen Self-Test" title="Packaging for Siemens Healthineer: CLINITEST Rapid COVID-19 Antigen Self-Test" class="img-responsive"> </div> </a></td> <td> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="b648d63e-4136-4cff-9790-3465855a047a" href="/media/162503/download?attachment" title="Siemens Healthineers: CLINITEST Rapid COVID-19 Antigen Self-Test Shelf Life Extension">Extended Expiration Date</a></li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 15 minutes</li> <li>Smartphone/Web access (optional)</li> <li>Shelf Life: 24 months</li> </ul> </td> </tr> <tr> <td> <p>Watmind USA:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="434fc325-ca75-48d6-9d75-39b8377c2abd" href="/media/159828/download?attachment" title="Speedy Swab Rapid COVID-19 Antigen Self-Test - IFU (Home Test)">Speedy Swab Rapid COVID-19 Antigen Self-Test</a></p> <a href="/media/160117/download"> <div alt="Packaging for Watmind USA: Speedy Swab Rapid COVID-19 Antigen Self-Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="square_1_1_112_x_112" data-entity-type="media" data-entity-uuid="807c86fe-4aef-409b-a910-151153afa05f" data-langcode="en" title="Packaging for Watmind USA: Speedy Swab Rapid COVID-19 Antigen Self-Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/square_1_1_112_x_112/public/COVID19-AtHomeTest-Picture23.jpg?itok=ZRMJeXfx" alt="Packaging for Watmind USA: Speedy Swab Rapid COVID-19 Antigen Self-Test" title="Packaging for Watmind USA: Speedy Swab Rapid COVID-19 Antigen Self-Test" class="img-responsive"> </div> </a></td> <td> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="4310f04d-b19a-4777-97c4-d09b2dbc8689" href="/media/165822/download?attachment" title="Speedy Swab Rapid COVID-19 Antigen Self-Test 6-month to 21-month shelf-life extension">Extended Expiration Date</a></li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing)</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 15 minutes</li> <li>Shelf Life: 21 months</li> </ul> </td> </tr> <tr> <td> <p>Xiamen Boson Biotech Co., Ltd.:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="7680fc85-5733-4988-b88c-4ea044f85d05" href="/media/157545/download?attachment" title="Boson Ag Test - Instruction for Use Home Test">Rapid SARS-CoV-2 Antigen Test Card</a></p> <a href="/media/160118/download"> <div alt="Packaging for Xiamen Boson Biotech Co., Ltd.: Rapid SARS-CoV-2 Antigen Test Card" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="square_1_1_112_x_112" data-entity-type="media" data-entity-uuid="f67bf572-af73-4a01-89e4-4e7f0db76d31" data-langcode="en" title="Packaging for Xiamen Boson Biotech Co., Ltd.: Rapid SARS-CoV-2 Antigen Test Card" class="embedded-entity"> <img loading="lazy" src="/files/styles/square_1_1_112_x_112/public/COVID19-AtHomeTest-Picture24.jpg?itok=zc2lTvpT" alt="Packaging for Xiamen Boson Biotech Co., Ltd.: Rapid SARS-CoV-2 Antigen Test Card" title="Packaging for Xiamen Boson Biotech Co., Ltd.: Rapid SARS-CoV-2 Antigen Test Card" class="img-responsive"> </div> </a></td> <td> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="2872eddc-81d0-4657-bd44-83214b1c356c" href="/media/168236/download?attachment" title="Xiamen Boson Rapid SARS-CoV-2 Antigen Test Card Extension">Extended Expiration Date</a></li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 15 minutes</li> <li>Shelf Life: 18 months</li> </ul> </td> </tr> <tr> <td> <p>SEKISUI Diagnostics, LLC.:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="3861e1c1-e1fd-4d4c-bf39-72db0a458e41" href="/media/163321/download?attachment" title="OSOM COVID-19 Antigen Home Test - Instructions for Use (Home Test)">OSOM COVID-19 Antigen Home Test</a></p> <div alt="OSOM COVID-19 Antigen Home Test - box label" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="landscape_16_9_200_x_112 Array" data-entity-type="media" data-entity-uuid="fc50d575-01dd-42a0-802c-c79be96f1a87" data-langcode="en" title="OSOM COVID-19 Antigen Home Test - box label" class="embedded-entity"> <img loading="lazy" src="/files/styles/landscape_16_9_200_x_112/public/EUA-SEKISUI-OSOMotc_BoxLabel.jpg?itok=L_5WfOGd" alt="OSOM COVID-19 Antigen Home Test - box label" title="OSOM COVID-19 Antigen Home Test - box label" class="img-responsive"> </div> </td> <td> <ul> <li>Expiration Date: See box label</li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 15-30 minutes</li> <li>Shelf Life: 11 months</li> </ul> </td> </tr> <tr> <td> <p>Beijing Hotgen Biotech Co., Ltd.:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="044cddc2-c8a1-429f-9525-032097d1d4c7" href="/media/163439/download?attachment" title="Hotgen COVID-19 Antigen Home Test - IFU (Home Test)">Hotgen COVID-19 Antigen Home Test</a></p> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="55e60ea6-de74-455c-b408-08a6ff011f2b" href="/media/163364/download?attachment" title="Packaging for Hotgen COVID-19 Antigen Home Test"> <div alt="Packaging for Hotgen COVID-19 Antigen Home Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="landscape_16_9_200_x_112" data-entity-type="media" data-entity-uuid="55e60ea6-de74-455c-b408-08a6ff011f2b" data-langcode="en" title="Packaging for Hotgen COVID-19 Antigen Home Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/landscape_16_9_200_x_112/public/COVID19-AtHomeTest-Hotgen.jpg?itok=IJc8S0Ko" alt="Packaging for Hotgen COVID-19 Antigen Home Test" title="Packaging for Hotgen COVID-19 Antigen Home Test" class="img-responsive"> </div> </a></td> <td> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="feb8cbd8-de2c-4689-95e9-909de382514a" href="/media/167722/download?attachment" title="Beijing Hotgen COVID-19 Antigen Home Test Extension ">Extended Expiration Date</a></li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 15-30 minutes</li> <li>Shelf Life: 10 months</li> </ul> </td> </tr> <tr> <td> <p>CorDX, Inc.:<br> <a href="/media/164118/download">CorDx COVID-19 Ag Test</a></p> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="1710e16a-3d91-4e22-a21a-82758f253917" href="/media/163450/download?attachment" title="Packaging for Axteria BioMed Consulting Inc.: CorDx COVID-19 Ag Test"> <div alt="Packaging for Axteria BioMed Consulting Inc.: CorDx COVID-19 Ag Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="portrait_3_4_112_x_150" data-entity-type="media" data-entity-uuid="1710e16a-3d91-4e22-a21a-82758f253917" data-langcode="en" title="Packaging for Axteria BioMed Consulting Inc.: CorDx COVID-19 Ag Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/portrait_3_4_112_x_150/public/EUA-AxteriaBioMed.jpg?itok=HeHIUGcF" alt="Packaging for Axteria BioMed Consulting Inc.: CorDx COVID-19 Ag Test" title="Packaging for Axteria BioMed Consulting Inc.: CorDx COVID-19 Ag Test" class="img-responsive"> </div> </a></td> <td> <ul> <li>Expiration Date: See box label</li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult </li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 10-30 minutes</li> <li>Shelf Life: 15 months</li> </ul> </td> </tr> <tr> <td> <p>Azure Biotech Inc.:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="3135ba57-06c4-4136-b964-a8abf8d842a6" href="/media/163448/download?attachment" title="Fastep COVID-19 Antigen Home Test - IFU (Home Test)">Fastep COVID-19 Antigen Home Test</a></p> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="c9ee194e-9fe9-4d99-94e0-0e0753b4df8a" href="/media/163451/download?attachment" title="Packaging for Azure Biotech Inc.: Fastep COVID-19 Antigen Home Test"> <div alt="Packaging for Azure Biotech Inc.: Fastep COVID-19 Antigen Home Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="landscape_16_9_200_x_112" data-entity-type="media" data-entity-uuid="c9ee194e-9fe9-4d99-94e0-0e0753b4df8a" data-langcode="en" title="Packaging for Azure Biotech Inc.: Fastep COVID-19 Antigen Home Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/landscape_16_9_200_x_112/public/EUA-AzureBiotech.jpg?itok=HgspyZjQ" alt="Packaging for Azure Biotech Inc.: Fastep COVID-19 Antigen Home Test" title="Packaging for Azure Biotech Inc.: Fastep COVID-19 Antigen Home Test" class="img-responsive"> </div> </a></td> <td> <ul> <li>Expiration Date: See box label</li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 15-30 minutes</li> <li>Shelf Life: 24 months</li> </ul> </td> </tr> <tr> <td> <p>Oceanit Foundry LLC:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="9f38f317-1739-4496-ae7a-29c596ae7c74" href="/media/164167/download?attachment" title="EUA Oceanit Assure100-OTC Instructions for Use Home Test">ASSURE-100 Rapid COVID-19</a></p> <div alt="Photo of Oceanit Assure Covid Test Box" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="landscape_16_9_200_x_112" data-entity-type="media" data-entity-uuid="9dc93ec7-25ce-4101-9b07-5a516e9f5339" data-langcode="en" title="Photo of Oceanit Assure Covid Test Box" class="embedded-entity"> <img loading="lazy" src="/files/styles/landscape_16_9_200_x_112/public/Oceanit_Assure_COVID%20test%20watermark.jpg?itok=jepjbrva" alt="Photo of Oceanit Assure Covid Test Box" title="Photo of Oceanit Assure Covid Test Box" class="img-responsive"> </div> </td> <td> <ul> <li>Expiration Date: See box label</li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 20-30 minutes</li> <li>Shelf Life: 12 months</li> </ul> </td> </tr> <tr> <td> <p>Advin Biotech Inc.:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="8e0d927d-2ed0-4b70-913c-f8770994ae9c" href="/media/164171/download?attachment" title="EUA AdvinBio COVID19-AgOTC Instructions for Use Home Test">Advin COVID-19 Antigen Test @Home</a></p> <div alt="Photo of AdvinBio_Covid16 Test box" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="landscape_16_9_200_x_112" data-entity-type="media" data-entity-uuid="9920d8cd-9cbe-4286-9e00-c1902c69267c" data-langcode="en" title="AdvinBio_Covid16 test" class="embedded-entity"> <img loading="lazy" src="/files/styles/landscape_16_9_200_x_112/public/AdvinBio_Covid16%20test%20watermark.jpg?itok=v1b9aE8Z" alt="Photo of AdvinBio_Covid16 Test box" title="AdvinBio_Covid16 test" class="img-responsive"> </div> </td> <td> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="8953c77e-8be4-4e33-972d-c288b4f9f2f0" href="/media/172663/download?attachment" title="Advin COVID-19 Antigen Test Home - Shelf Life Extended">Extended Expiration Date</a></li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 15-30 minutes</li> <li>Shelf Life:  24 months</li> </ul> </td> </tr> <tr> <td> <p>GenBody Inc.:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ec0a81ce-003a-47b1-8a0b-32169cddcc24" href="/media/165517/download?attachment" title="GenBody COVID-19 Ag Home Test - IFU (Home Test)">GenBody COVID-19 Ag Home Test</a></p> <a href="/media/165518/download"> <div alt="Image of the GenBody COVID-19 Ag Home Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="portrait_3_4_112_x_150 Array" data-entity-type="media" data-entity-uuid="4ac98508-2144-4f2e-ad78-4467f4a21cf6" data-langcode="en" title="GenBody COVID-19 Ag Home Test - Box Image" class="embedded-entity"> <img loading="lazy" src="/files/styles/portrait_3_4_112_x_150/public/EUA-GenBody-HomeoTC-BoxLabel.jpg?itok=FMkPbDwo" alt="Image of the GenBody COVID-19 Ag Home Test" title="GenBody COVID-19 Ag Home Test - Box Image" class="img-responsive"> </div> </a></td> <td> <ul> <li>Expiration Date: See box label</li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 15-20 minutes</li> <li>Shelf Life: 24 months</li> </ul> </td> </tr> <tr> <td> <p>Azure Biotech, Inc.:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="158ba52a-33a4-4183-b680-a5ca03c768a8" href="/media/167197/download?attachment" title="Azure FaStep® COVID-19 Antigen Pen Home Test - Instructions for Use (Home Test)">Azure FaStep® COVID-19 Antigen Pen Home Test</a></p> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="cdff901a-a7a8-4fad-8b4c-49c84f82b102" href="/media/167200/download?attachment" title="Azure FaStep® COVID-19 Antigen Pen Home Test Box Label"> <div alt="Azure FaStep® COVID-19 Antigen Pen Home Test Box Label" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="Array" data-entity-type="media" data-entity-uuid="493083c6-d87c-4a85-b780-6bce31a82a2c" data-langcode="en" title="Azure FaStep® COVID-19 Antigen Pen Home Test Box Label" class="embedded-entity"> <img loading="lazy" src="/files/Azure_FaStepAgPenOTC_BoxLabel.jpg" alt="Azure FaStep® COVID-19 Antigen Pen Home Test Box Label" title="Azure FaStep® COVID-19 Antigen Pen Home Test Box Label" class="img-responsive"> </div> </a></td> <td> <ul> <li>Expiration Date: See box label</li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult </li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 15-30 minutes</li> <li>Shelf Life: 21 months</li> </ul> </td> </tr> <tr> <td> <p>Pfizer Inc.:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="1dbddfc7-a7b5-4a03-9bd8-21ce052f6ae8" href="/media/165691/download?attachment" title="Lucira by Pfizer COVID-19 & Flu Home Test - IFU (Home Test)">Lucira by Pfizer COVID-19 & Flu Home Test</a></p> <a href="/media/165694/download"> <div alt="Lucira COVID-19 & Flu Home Test - Box Label" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="portrait_3_4_112_x_150 Array" data-entity-type="media" data-entity-uuid="612635cc-ff57-4d43-8ec9-f09f651bb623" data-langcode="en" title="Lucira COVID-19 & Flu Home Test - Box Label" class="embedded-entity"> <img loading="lazy" src="/files/styles/portrait_3_4_112_x_150/public/EUA-Pfizer-COVIDFlu-OTC-BoxLabel_0.jpg?itok=CpohUpr-" alt="Lucira COVID-19 & Flu Home Test - Box Label" title="Lucira COVID-19 & Flu Home Test - Box Label" class="img-responsive"> </div> </a></td> <td> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="bc5576d5-33ea-475c-ab7e-1882612bb242" href="/media/170703/download?attachment" title="Lucira by Pfizer COVID-19 and Flu Home Test - Extended Expiration Date">Extended Expiration Date</a></li> </ul> </td> <td> <ul> <li>People with symptoms</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Molecular test</li> <li>Nasal swab</li> <li>Results in 30 minutes</li> <li>Shelf Life: 18 months</li> </ul> </td> </tr> <tr> <td> <p>Princeton BioMeditech Corp:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="78395821-8fe2-4cb6-b6e3-06f16839c195" href="/media/167680/download?attachment" title="Status COVID-19 Antigen Rapid Test for Home Use - IFU (Home Test)">Status COVID-19 Antigen Rapid Test for Home Use</a></p> <a href="/media/167691/download"> <div alt="Princeton Status COVID-19 Antigen" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="landscape_16_9_200_x_112 Array" data-entity-type="media" data-entity-uuid="70a0365a-952a-4950-a367-baf570ef7c63" data-langcode="en" title="Princeton-StatusAgOTC_BoxLabel.jpg" class="embedded-entity"> <img loading="lazy" src="/files/styles/landscape_16_9_200_x_112/public/Princeton-StatusAgOTC_BoxLabel.jpg?itok=G54zGbb1" alt="Princeton Status COVID-19 Antigen" title="Princeton-StatusAgOTC_BoxLabel.jpg" class="img-responsive"> </div> </a></td> <td> <ul> <li>Expiration Date: See box label</li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 15 minutes</li> <li>Shelf Life: 24 months</li> </ul> </td> </tr> <tr> <td> <p>Nano-Ditech Corporation:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="c3ac6f96-0993-4212-af03-a0deb5d38a5d" href="/media/168196/download?attachment" title="Nano-Check COVID-19 Antigen At-Home Test - IFU (Home Test)">Nano-Check COVID-19 Antigen At-Home Test</a></p> <a href="/media/168197/download"> <div alt="Packaging illustration" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="landscape_16_9_200_x_112 Array" data-entity-type="media" data-entity-uuid="ab1dbd79-8909-421e-a0f5-465d8156c237" data-langcode="en" title="Nano-Check COVID-19 Antigen At-Home Test - Box Label" class="embedded-entity"> <img loading="lazy" src="/files/styles/landscape_16_9_200_x_112/public/EUA-Nano-Check-AgOTC_BoxLabel.jpg?itok=rp0KUdlz" alt="Packaging illustration" title="Nano-Check COVID-19 Antigen At-Home Test - Box Label" class="img-responsive"> </div> </a></td> <td> <ul> <li>Expiration Date: See box label </li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult </li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 15 minutes </li> <li>Shelf Life: 6 months </li> </ul> </td> </tr> <tr> <td> <p>BioTeke USA, LLC:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="6ec69b89-cc62-40f6-ab95-df269e15f976" href="/media/168485/download?attachment" title="Bio-Self COVID-19 Antigen Home Test - IFU (Home Test)">Bio-Self COVID-19 Antigen Home Test</a></p> <a href="/media/168486/download"> <div alt="Packaging for Bio-Self COVID-19 Antigen Home Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="portrait_3_4_225_x_300 Array" data-entity-type="media" data-entity-uuid="5904c034-06ab-4a58-b126-29229cb4a0ba" data-langcode="en" title="Packaging for Bio-Self COVID-19 Antigen Home Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/portrait_3_4_225_x_300/public/OTC-EUA-BioTeke.jpg?itok=9dzuJPAn" alt="Packaging for Bio-Self COVID-19 Antigen Home Test" title="Packaging for Bio-Self COVID-19 Antigen Home Test" class="img-responsive"> </div> </a></td> <td> <ul> <li>Expiration Date: See box label</li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).</li> <li>People without symptoms. The test is to be performed three times over five days (serial testing)</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 15-30 minutes</li> <li>Shelf Life: 12 months</li> </ul> </td> </tr> <tr> <td> <p>3EO Health, Inc.:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="52ebf263-ed57-4c51-8a67-043a2ca5d9b0" href="/media/172393/download?attachment" title="3EO Health COVID-19 Test - Instructions for Use Home Test">3EO Health COVID-19 Test</a></p> <div alt="Packaging for 3EO Health COVID-19 Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="portrait_3_4_225_x_300 Array" data-entity-type="media" data-entity-uuid="f26a7dcb-990c-45d5-ba5c-da4f93afc187" data-langcode="en" title="Packaging for 3EO Health COVID-19 Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/portrait_3_4_225_x_300/public/3EOHealth_COVIDOTC_watermark.jpg?itok=o2yo5yzl" alt="Packaging for 3EO Health COVID-19 Test" title="Packaging for 3EO Health COVID-19 Test" class="img-responsive"> </div> </td> <td> <ul> <li>Expiration Date: See box label</li> </ul> </td> <td> <ul> <li>People with symptoms.</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Molecular test</li> <li>Nasal swab</li> <li>Results in 30 minutes</li> <li>Shelf Life: 4 months</li> </ul> </td> </tr> <tr> <td> <p>SEKISUI Diagnostics, LLC:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="436d1cbb-8f3a-4eaa-9973-28bbcca13ada" href="/media/176731/download?attachment" title="OSOM Flu SARS-CoV-2 Combo Home Test - IFU (Home Test)">OSOM Flu SARS-CoV-2 Combo Home Test</a></p> <div alt="Packaging for SEKISUI Diagnostics, LLC: OSOM Flu SARS-CoV-2 Combo Home Test" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="portrait_3_4_225_x_300 Array" data-entity-type="media" data-entity-uuid="60355a61-c66c-4fc4-bb0f-4b2105b1c9b5" data-langcode="en" title="Packaging for SEKISUI Diagnostics, LLC: OSOM Flu SARS-CoV-2 Combo Home Test" class="embedded-entity"> <img loading="lazy" src="/files/styles/portrait_3_4_225_x_300/public/EUA-Sekisui-FluCOVID-Home_BoxLabel.jpg?itok=ks-I_IXx" alt="Packaging for SEKISUI Diagnostics, LLC: OSOM Flu SARS-CoV-2 Combo Home Test" title="Packaging for SEKISUI Diagnostics, LLC: OSOM Flu SARS-CoV-2 Combo Home Test" class="img-responsive"> </div> </td> <td> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="b9dddd64-1c23-4db0-b84a-80477e88be8b" href="/media/182084/download?attachment" title="OSOM Flu SARS-CoV-2 Combo Home Test 6 month to 12 month shelf-life extension">Extended Expiration Date</a></li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 4 days. The test is to be performed two times over three days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 10-30 minutes</li> <li>Shelf Life: 12 months</li> </ul> </td> </tr> <tr> <td> <p>Wondfo USA Co., Ltd.<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d9038caf-0a36-4444-992e-ffcdd1fe9486" href="/media/178462/download?attachment" title="WELLlife COVID-19-Influenza A&B Home Test IFU Home Test">WELLlife COVID-19 / Influenza A&B Home Test</a></p> <div alt="EUA-WELLLife Flu COVID OTC Box Label" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="portrait_3_4_225_x_300 Array" data-entity-type="media" data-entity-uuid="1dd9ca28-11e8-4751-8ed0-ed575f9b28b5" data-langcode="en" title="EUA-WELLLife Flu COVID OTC Box Label" class="embedded-entity"> <img loading="lazy" src="/files/styles/portrait_3_4_225_x_300/public/EUA-WELLLife-Flu%20COVIDOTC-BoxLabel.jpg?itok=OUCzL8s9" alt="EUA-WELLLife Flu COVID OTC Box Label" title="EUA-WELLLife Flu COVID OTC Box Label" class="img-responsive"> </div> </td> <td> <ul> <li>Expiration Date: See box label</li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 10 minutes</li> <li>Shelf Life: 6 months</li> </ul> </td> </tr> <tr> <td> <p>iHealth Labs, Inc.:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="7a4a1c89-14db-4fca-a287-eb5e86f9f36c" href="/media/178554/download?attachment" title="iHealth COVID-19/Flu A&B Rapid Test - IFU (Home Test)">iHealth COVID-19/Flu A&B Rapid Test</a></p> <div alt="iHealth Labs, Inc.: iHealth COVID-19/Flu A&B Rapid Test Product labeling" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="portrait_3_4_225_x_300 Array" data-entity-type="media" data-entity-uuid="a9fee5d6-5c1d-41c5-9af5-76d2b4447649" data-langcode="en" title="iHealth Labs, Inc.: iHealth COVID-19/Flu A&B Rapid Test Product labeling" class="embedded-entity"> <img loading="lazy" src="/files/styles/portrait_3_4_225_x_300/public/EUA-iHealth-COVID-Flu-OTC_BoxLabel.jpg?itok=PWHGoFz1" alt="iHealth Labs, Inc.: iHealth COVID-19/Flu A&B Rapid Test Product labeling" title="iHealth Labs, Inc.: iHealth COVID-19/Flu A&B Rapid Test Product labeling" class="img-responsive"> </div> </td> <td> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="1a1d814b-2b2c-4bd2-b660-14b4451148f5" href="/media/183139/download?attachment" title="iHealth COVID-19/Flu A&B Rapid Test - 14 to 17 Month Shelf-Life Extension">Extended Expiration Date</a></li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 4 days. The test is to be performed two times over three days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult</li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 15 minutes</li> <li>Shelf Life: 17 months</li> </ul> </td> </tr> <tr> <td> <p>ACON Laboratories, Inc.:<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="9162f4cf-85ed-404f-800f-283f3125a218" href="/media/180807/download?attachment" title="Flowflex Plus COVID-19 and Flu A/B Home Test - IFU (Home Test)">Flowflex Plus COVID-19 and Flu A/B Home Test</a></p> <div alt="Flowflex Plus COVID-19 and Flu A/B Home Test - Image of Packaging" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="landscape_16_9_200_x_112 Array" data-entity-type="media" data-entity-uuid="7ca8703d-f4d1-4a83-86d3-1bd76fdbda0e" data-langcode="en" title="Flowflex Plus COVID-19 and Flu A/B Home Test - Image of Packaging" class="embedded-entity"> <img loading="lazy" src="/files/styles/landscape_16_9_200_x_112/public/EUA-ACON-flu-CovidOTC-Packaging.jpg?itok=xz9jP7uQ" alt="Flowflex Plus COVID-19 and Flu A/B Home Test - Image of Packaging" title="Flowflex Plus COVID-19 and Flu A/B Home Test - Image of Packaging" class="img-responsive"> </div> </td> <td> <ul> <li>Expiration Date: See box label</li> </ul> </td> <td> <ul> <li>People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing).</li> </ul> </td> <td> <ul> <li>Age 14 years and older</li> <li>Age 2 years and older when collected by an adult </li> </ul> </td> <td> <ul> <li>Antigen test</li> <li>Nasal swab</li> <li>Results in 15 minutes</li> <li>Shelf Life: 15 months</li> </ul> </td> </tr> </tbody> </table> </div> <h2><a name="Related"></a>Related Information:</h2> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="5325f762-77b2-436f-a3fd-6411c384b89b" href="/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-tests-granted-traditional-marketing-authorization-fda" title="COVID-19 Tests Granted Traditional Marketing Authorization by the FDA">COVID-19 Tests Granted Traditional Marketing Authorization by the FDA</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="34e8b0ff-b511-42b1-a25f-43f676a45a3f" href="/medical-devices/coronavirus-covid-19-and-medical-devices/understanding-home-otc-covid-19-antigen-diagnostic-test-results" title="Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results">Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="1d2b7568-07ab-4083-ab7b-25359f60533f" href="/medical-devices/coronavirus-covid-19-and-medical-devices/home-covid-19-diagnostic-tests-frequently-asked-questions" title="At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions">At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="c24d48f4-b23c-47e6-b491-38dd7d025df2" href="/consumers/consumer-updates/covid-19-test-basics" title="COVID-19 Test Basics">COVID-19 Test Basics:</a> Includes details on COVID-19 tests, types of samples, and other information.</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="20e6f922-1536-4295-9f4e-45580d94c7a7" href="/medical-devices/safety-communications/home-covid-19-antigen-tests-take-steps-reduce-your-risk-false-negative-results-fda-safety" title="At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative Results: FDA Safety Communication">At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication</a></li> <li><a href="/medical-devices/coronavirus-covid-19-and-medical-devices/counterfeit-home-otc-covid-19-diagnostic-tests">Counterfeit At-Home OTC COVID-19 Diagnostic Tests</a></li> <li>Find COVID-19 Tests at <a href="https://www.covid.gov/tests">COVID.gov/tests</a></li> <li>Video: <a href="https://www.youtube.com/watch?v=yoZL1BVP9Bs">How to Interpret Self-Test Results | CDC</a></li> <li><a href="https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html">COVID-19 Testing: What You Need to Know | CDC</a></li> <li><a href="https://www.cdc.gov/coronavirus/2019-ncov/testing/self-testing.html">COVID-19 Self-Testing At-Home or Anywhere | CDC</a></li> <li><a href="https://archive.cdc.gov/#/details?q=https://www.cdc.gov/coronavirus/2019-ncov/your-health/if-you-were-exposed.html&start=0&rows=10&url=https://www.cdc.gov/coronavirus/2019-ncov/your-health/if-you-were-exposed.html">What to Do If You Were Exposed to COVID-19 | CDC</a></li> <li><a href="https://archive.cdc.gov/#/details?q=https://www.cdc.gov/coronavirus/2019-ncov/your-health/isolation.html&start=0&rows=10&url=https://www.cdc.gov/coronavirus/2019-ncov/downloads/your-health/isolation-print-resource-final.pdf">Isolation and Precautions for People with COVID-19 | CDC</a></li> <li>Video: <a href="https://www.youtube.com/watch?app=desktop&v=iGkwaESsGBQ&feature=youtu.be">What Is an EUA?</a> Describes how the FDA can issue an emergency use authorization (EUA) to provide more timely access to diagnostic tests that may help during the public health emergency when there is no adequate, approved, and available alternative.</li> </ul> <ul class="footnotes"> <li class="footnote" id="footnote1_eh5dgqy"><a class="footnote-label" href="#footnoteref1_eh5dgqy">1</a>The Pilot COVID-19 At-Home Test, distributed by Roche Diagnostics, is previously known as the COVID-19 At-Home Test. As the manufacturer, SD Biosensor, transitions to this new brand, customers may receive a product with the previously authorized COVID-19 At-Home Test labeling. </li> </ul>   </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top"> <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Content current as of:</h2> <p class="lcds-description-list__item-text"><time datetime="2024-11-18T00:00:00Z">11/18/2024</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Regulated Product(s)</h2> <ul role="menu" class="lcds-metadata-list"> <li role="menuitem">Medical Devices</li> </ul> </div> </li> </ul> </aside> </div> </section> </aside> <aside class="col-md-2 col-md-pull-10" role="complementary"> <section id="block-entityviewcontent-3" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <nav id="section-nav"class="lcds-card lcds-section-nav lcds-section-nav--side hidden-xs hidden-sm"> <ul class="lcds-section-nav__list lcds-section-nav--side__list"> <li> <a href="/medical-devices/emergency-situations-medical-devices/coronavirus-covid-19-and-medical-devices" class="lcds-section-nav__link lcds-section-nav--side__link lcds-section-nav__parent-link lcds-section-nav--side__parent-link"> Coronavirus (COVID-19) and Medical Devices </a> <div class="views-element-container form-group"><div class="view view-in-this-section view-id-in_this_section view-display-id-block_4 js-view-dom-id-94c5f13799b79a5d4f5ac1f02ec611d0fd7c29dc2ee1754767ddb55e89cabadf"> <div class="item-list"> <ul class="lcds-section-nav__active lcds-section-nav__list lcds-section-nav--side__list"> <li><a href="/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests" class="lcds-section-nav__link lcds-section-nav--side__link">At-Home OTC COVID-19 Diagnostic Tests</a></li> <li><a href="/medical-devices/coronavirus-covid-19-and-medical-devices/counterfeit-home-otc-covid-19-diagnostic-tests" class="lcds-section-nav__link lcds-section-nav--side__link">Counterfeit At-Home OTC COVID-19 Diagnostic Tests</a></li> <li><a href="/medical-devices/coronavirus-covid-19-and-medical-devices/home-covid-19-diagnostic-tests-frequently-asked-questions" class="lcds-section-nav__link lcds-section-nav--side__link">At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions</a></li> <li><a href="/medical-devices/coronavirus-covid-19-and-medical-devices/antibody-serology-testing-covid-19-information-patients-and-consumers" class="lcds-section-nav__link lcds-section-nav--side__link">Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers</a></li> <li><a href="/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-tests-granted-traditional-marketing-authorization-fda" class="lcds-section-nav__link lcds-section-nav--side__link">COVID-19 Tests Granted Traditional Marketing Authorization by the FDA</a></li> <li><a href="/medical-devices/coronavirus-covid-19-and-medical-devices/face-masks-barrier-face-coverings-surgical-masks-and-respirators-covid-19" class="lcds-section-nav__link lcds-section-nav--side__link">Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19</a></li> <li><a href="/medical-devices/coronavirus-covid-19-and-medical-devices/adverse-event-reporting-medical-devices-under-emergency-use-authorization-eua" class="lcds-section-nav__link lcds-section-nav--side__link">Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA)</a></li> <li><a href="/medical-devices/coronavirus-covid-19-and-medical-devices/contacts-medical-devices-related-covid-19" class="lcds-section-nav__link lcds-section-nav--side__link">Contacts for Medical Devices Related to COVID-19</a></li> </ul> </div> </div> </div> <div class="views-element-container form-group"><div class="view view-in-this-section-sub view-id-in_this_section_sub view-display-id-block_1 js-view-dom-id-8780ea84a9a2be35fd8d2a2067f60ca54cf296d34490cf6d841432d69883aa42"> </div> </div> </li> </ul> </nav> </div> </section> </aside> </article> </main> </div> </div> <div class="region region-subscribe"> <section id="block-entityviewcontent-5" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <section class="lcds-subscribe" id="subscribe"> <div class="row"> <div class="col-sm-12 col-md-3 col-md-offset-3"> <h2>Subscribe to Consumer Information for Medical Devices</h2> <p>Receive notifications for consumers about medical device information, recently approved devices, and alerts that may be of interest to the general public.</p> </div> <div class="col-sm-12 col-md-3"> <form class="form-horizontal" id="GD-snippet-form" action="https://public.govdelivery.com/accounts/USFDA/subscribers/qualify" accept-charset="UTF-8" method="post"> <input name="utf8" type="hidden" value="✓"> <input type="hidden" name="authenticity_token" value="VJuyc1HyD63+xVCkN+K9qiH1bD9zSSJ+BfdR1d4LXjZ0BncrJ/u9dEw/e0U869OeCw6JxhyYXfnZCCGNF1oVkQ=="> <input type="hidden" name="topic_id" id="topic_id" value="USFDA_70"> <label class="sr-only" for="email">Enter your email address to subscribe:</label> <div class="input-group subscribe-group"> <input type="email" name="email" id="email" placeholder="Email Address" class="form-control"> <span class="input-group-btn"><input class="btn btn-primary" type="submit" name="commit" value="Subscribe"></span> </div> </form> </div> </div> </section> </section> </div> <footer class="lcds-footer container-fluid"> <div class="row lcds-footer__primary"> <h2 id="footer-heading" class="sr-only">Footer Links</h2> <nav class="text-center"> <div class="col-sm-4"> <ul class="nav"> <li><a href="/about-fda/about-website/fdagov-archive" >FDA Archive</a></li> <li><a href="/about-fda" >About FDA</a></li> <li><a href="/about-fda/about-website/internet-accessibility" >Accessibility</a></li> </ul> </div> <div class="col-sm-4"> <ul class="nav"> <li><a href="/about-fda/visitor-information" >Visitor Information</a> </li> <li><a href="/about-fda/about-website/website-policies" >Website Policies / Privacy</a></li> <li><a href="/about-fda/jobs-and-training-fda/no-fear-act" >No FEAR Act</a></li> <li><a href="https://www.hhs.gov/vulnerability-disclosure-policy/index.html" >Vulnerability Disclosure Policy</a></li> </ul> </div> <div class="col-sm-4"> <ul class="nav"> <li><a href="/regulatory-information/freedom-information" title="Freedom of Information Act">FOIA</a></li> <li><a href="https://www.hhs.gov/" title="Health and Human Services" target="_blank">HHS.gov</a></li> <li><a href="https://www.usa.gov/" target="_blank">USA.gov</a></li> </ul> </div> </nav> </div> <div class="row lcds-footer__secondary"> <div class="col-sm-12 col-md-6 col-lg-4 lcds-footer__social-links"> <a href="/about-fda/contact-fda" class="btn btn-default btn-md">Contact FDA</a> <a href="https://www.facebook.com/FDA" title="Follow FDA on Facebook" class="no-disclaimer"> <span class="fa fa-facebook fa-2x" aria-hidden="true"> <span class="sr-only">Follow FDA on Facebook</span> </span> </a> <a href="https://x.com/US_FDA" title="Follow FDA on X" class="no-disclaimer"> <svg class="icon-svg-inline fa-2x" aria-hidden="true"> <use href="/themes/custom/preview/assets/images/fa-icons.svg#icon-x-twitter"> </svg> <span class="sr-only">Follow FDA on X</span> </a> <a href="https://instagram.com/FDA" title="Follow FDA on Instagram" class="no-disclaimer"> <span class="fa fa-instagram fa-2x" aria-hidden="true"> <span class="sr-only">Follow FDA on Instagram</span> </span> </a> <br class='visible-xs-inline'/> <a href="https://www.linkedin.com/company/fda/" title="Follow FDA on LinkedIn" class="no-disclaimer"> <span class="fa fa-linkedin fa-2x" aria-hidden="true"> <span class="sr-only">Follow FDA on LinkedIn</span> </span> </a> <a href="https://youtube.com/@US_FDA" title="View FDA videos on YouTube" class="no-disclaimer"> <span class="fa fa-youtube fa-2x" aria-hidden="true"> <span class="sr-only">View FDA videos on YouTube</span> </span> </a> <a href="/about-fda/contact-fda/subscribe-podcasts-and-news-feeds" title="Subscribe to FDA RSS feeds"> <span class="fa fa-rss fa-2x" aria-hidden="true"> <span class="sr-only">Subscribe to FDA RSS feeds</span> </span> </a> </div> <a href="/" title="FDA Homepage"> <div class="visible-lg-block col-lg-4 text-center lcds-footer__logo"> <span class="sr-only">FDA Homepage</span> </div> </a> <div class="col-sm-12 col-md-6 col-lg-4 text-center lcds-footer__contact-number"> <span class="fa fa-phone" aria-hidden="true"> </span> <span class="sr-only">Contact Number</span> 1-888-INFO-FDA (1-888-463-6332) </div> </div>  </footer> <a href="" id="btn-top" class="btn btn-primary btn-top"><span class="sr-only">Back to </span>Top</a> </div> <script type="application/json" data-drupal-selector="drupal-settings-json">{"path":{"baseUrl":"\/","pathPrefix":"","currentPath":"node\/412786","currentPathIsAdmin":false,"isFront":false,"currentLanguage":"en"},"pluralDelimiter":"\u0003","suppressDeprecationErrors":true,"fda_ckeditor_enhancements":{"basePath":"modules\/custom\/fda_ckeditor_enhancements"},"google_analytics":{"account":"G-273DTKB5QW","trackOutbound":true,"trackMailto":true,"trackTel":true,"trackDownload":true,"trackDownloadExtensions":"7z|aac|arc|arj|asf|asx|avi|bin|csv|doc(x|m)?|dot(x|m)?|exe|flv|gif|gz|gzip|hqx|jar|jpe?g|js|mp(2|3|4|e?g)|mov(ie)?|msi|msp|pdf|phps|png|ppt(x|m)?|pot(x|m)?|pps(x|m)?|ppam|sld(x|m)?|thmx|qtm?|ra(m|r)?|sea|sit|tar|tgz|torrent|txt|wav|wma|wmv|wpd|xls(x|m|b)?|xlt(x|m)|xlam|xml|z|zip"},"bootstrap":{"forms_has_error_value_toggle":1,"modal_animation":1,"modal_backdrop":"true","modal_focus_input":1,"modal_keyboard":1,"modal_select_text":1,"modal_show":1,"modal_size":"","popover_enabled":1,"popover_animation":1,"popover_auto_close":1,"popover_container":"body","popover_content":"","popover_delay":"0","popover_html":0,"popover_placement":"right","popover_selector":"","popover_title":"","popover_trigger":"click"},"ajax":[],"user":{"uid":0,"permissionsHash":"3aef67b4ac7d861d8624bf1f7ab2bc9cfc56d3c25b7d709dc15466dfa996dfb0"}}</script> <script src="/files/js/js_9lof_6HXyxkDc120118GyOuNF6pAPfd8qWfA4s8VzMo.js?scope=footer&delta=0&language=en&theme=preview&include=eJxlT9GOwjAM-6GO3stJ_E2VtVmpaOuqyYHG17OB2IBTpMiyldieUJWuLChspx0fTARiZkeV8qzJi_0mjMyiXOxIwqZ1viS-2pgxUh5E55xq_Ef7npqKGQEV7dRsQ8OFu5kCOX_mkBTdcT1R9Vy4qljyHj0kVKeIawA5oatH2E2X4yGQLjNmlg_69fNdX0Wxj30oCH-Zn_YoLafV-Km535_jG2mmJXSFstgNbVa-023muBcO1D4ibqGHrc8deO2Utg"></script> <script src="/libraries/datatables/media/js/jquery.dataTables.min.js?smjbjq"></script> <script src="/files/js/js_Kgn7Gfixu9Cij2aqLSPPKkV1t0TIACwjRX4Nqc3nnp8.js?scope=footer&delta=2&language=en&theme=preview&include=eJxlT9GOwjAM-6GO3stJ_E2VtVmpaOuqyYHG17OB2IBTpMiyldieUJWuLChspx0fTARiZkeV8qzJi_0mjMyiXOxIwqZ1viS-2pgxUh5E55xq_Ef7npqKGQEV7dRsQ8OFu5kCOX_mkBTdcT1R9Vy4qljyHj0kVKeIawA5oatH2E2X4yGQLjNmlg_69fNdX0Wxj30oCH-Zn_YoLafV-Km535_jG2mmJXSFstgNbVa-023muBcO1D4ibqGHrc8deO2Utg"></script> <script src="/libraries/datatables/extensions/Responsive/js/dataTables.responsive.min.js?smjbjq"></script> <script src="/libraries/datatables/media/js/dataTables.bootstrap4.min.js?smjbjq"></script> <script src="/files/js/js_yRvZK9FXPiajh0GtgATd54O7-xucHKewYOldB6HcH8Y.js?scope=footer&delta=5&language=en&theme=preview&include=eJxlT9GOwjAM-6GO3stJ_E2VtVmpaOuqyYHG17OB2IBTpMiyldieUJWuLChspx0fTARiZkeV8qzJi_0mjMyiXOxIwqZ1viS-2pgxUh5E55xq_Ef7npqKGQEV7dRsQ8OFu5kCOX_mkBTdcT1R9Vy4qljyHj0kVKeIawA5oatH2E2X4yGQLjNmlg_69fNdX0Wxj30oCH-Zn_YoLafV-Km535_jG2mmJXSFstgNbVa-023muBcO1D4ibqGHrc8deO2Utg"></script> <script type="text/javascript" src="/MGkYvHozNLX70hFiNg/uruSNXkrXwQL/Rz9EDlMEJRE/AA56M/gVoB28"></script></body> </html>