CLIA - Clinical Laboratory Improvement Amendments

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For Test System Name/Manufacturer: enter a single word (e.g., Analyzer) or an exact phrase (e.g., Acme Analyzer). </p> <p><a href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm124105.htm" style="text-decoration:underline;">Learn More...</a></p> </div> <div id="clia-form"> <form name="BasicSearch" id="BasicSearch" action="results.cfm" method="post" onsubmit="return _CF_checkBasicSearch(this)"> <table width="100%" id="clia-form-title"> <tr> <td id="clia-form-title-left">Search Database</td> <td id="clia-form-title-right"><a href="/scripts/cdrh/cfdocs/search/default.cfm?FAQ=true"><img src="/scripts/cdrh/cfdocs/images/questionmark.gif"></a> <a href="javascript: alert('Enter any combination of fields and select Search.\n\nYou can use the Analyte Drop Down box to select a specific Analyte.\n\nTest System Name/Manufacturer Enter a single word (e.g., Analyzer) or an exact phrase (e.g., Acme Analyzer) .\n\nHints: Searches are not case sensitive. If you use too many words or misspell a word, you may not find what you are looking for.');">Help</a> <a href="https://www.fda.gov/medical-devices/medical-device-databases/clinical-laboratory-improvement-amendments-download-data"><img src="/scripts/cdrh/cfdocs/images/download.gif"></a> <A href="https://www.fda.gov/medical-devices/medical-device-databases/clinical-laboratory-improvement-amendments-download-data">Download Files</A> </td> </tr> </table> <table bgcolor="#f9f9f3" width="100%"> <TR VALIGN="top"> <TD BGCOLOR="#f9f9f3"> <TABLE BORDER="0" CELLPADDING="5" CELLSPACING="0" WIDTH="100%"> <TR> <TD ALIGN="left" ><label for="Test_System_Name">Test System / Manufacturer</label></td> <TD ALIGN="left" ><INPUT TYPE="text" NAME="Test_System_Name" ID="Test_System_Name" SIZE="40" MAXLENGTH="40"></td> </tr> <TR> <TD ALIGN="left" nowrap> <label for="Analyte_Name">Analyte Name</label>         <label for="sAN2">Show Drop Down</label> <input type="Checkbox" name="sAN2" 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contains valid export certificates submitted electronically via CECATS (CDRH Export Certification Application and Tracking System) and issued by the Center for Devices and Radiological Health.">CDRH Export Certificate Validation (CECV)</a></li> <li><a href="/scripts/cdrh/devicesatfda/readingroom.cfm" title="CDRH FOIA Electronic Reading Room.">CDRH FOIA Electronic Reading Room</a></li> <li><a href="/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm" title="Database of the most recent revision of Title 21 of the Code of Federal Regulations (CFR) from the Government Printing Office (GPO). 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">Humanitarian Device Exemption </a></li> <li><a href="/scripts/cdrh/cfdocs/Medsun/searchReportText.cfm" title="The Medical Product Safety Network (MedSun) improves FDA’s understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns.">Medsun Reports</a></li> <li><a href="/scripts/cdrh/cfdocs/cfPMA/pma.cfm" title="Database of Class III devices that support or sustain human life or are of substantial importance in preventing impairment of human health.">Premarket Approvals (PMAs)</a></li> <li><a href="/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm" title="Database of Post-Approval Studies">Post-Approval Studies</a></li> <li><a href="/scripts/cdrh/cfdocs/cfPMA/pss.cfm" title="Database of Postmarket Surveillance Studies">Postmarket Surveillance Studies</a></li> <li><a href="/scripts/cdrh/cfdocs/cfPCD_RH/classification.cfm" title="The Radiation-Emitting Electronic Product Codes Database contains names of radiation-emitting electronic products and devices and associated information developed by the Center for Devices and Radiological Health (CDRH) in support of its mission. This database contains product names and their associated product codes. Additionally, the radiation type, definition, and applicable performance standards (21 CFR Parts 1020-1050) are provided.">Radiation-Emitting Products</a></li> <li><a href="/scripts/cdrh/cfdocs/cfPCD_RH/rh_res.cfm" title="Electronic products for which manufacturers are required to perform corrective actions when a radiation safety problem exists that was caused by the design, manufacturing, or assembly of the product.">Radiation-Emitting Electronic Products Corrective Actions</a></li> <li><a href="/scripts/cdrh/cfdocs/cfRES/res.cfm" title="Database of classified medical device recalls since November 1, 2002.">Recalls</a></li> <li><a href="/scripts/cdrh/cfdocs/cfRL/rl.cfm" title="Database of devices in commercial distribution in the United States submitted by domestic and foreign manufacturers and medical device establishment information submitted by domestic and foreign establishments.">Registration & Listing</a></li> <li><a href="/scripts/cdrh/cfdocs/cfStandards/search.cfm" title="Database of Recognized Consensus Standards with associated FDA, medical device and standards industry information.">Standards</a></li> <li><a href="/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm" title="The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases including Premarket Approvals (PMA), Premarket Notifications (510[k]), Adverse Events, and Recalls.">Total Product Life Cycle</a></li> <li><a href="/scripts/cdrh/cfdocs/cfAssem/assembler.cfm" title="Database of locations and identities of certified components of diagnostic x-ray systems for routine compliance testing at user facilities. 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