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U.S. Department of Health and Human Services

Manufacturer and User Facility Device Experience (MAUDE)
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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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500 records meeting your search criteria returned. The results are incomplete - please narrow your search.

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ManufacturerBrand NameDate Report Received
Unknown Manufacturer QUICKVUE RAPID ANTIGEN 12/28/2021
Unknown Manufacturer QUICKVUE RAPID ANTIGEN 12/28/2021
Unknown Manufacturer RAPID COVID TEST 12/28/2021
QUIDEL CORP. QUICKVUE OTC AT HOME COVID TEST 12/28/2021
ELLUME LIMITED COVID-19 HOME TEST 12/28/2021
ABBOTT BINAXNOW COVID TEST 12/28/2021
ABBOTT BINAXNOW COVID-19 ANTIGEN SELF TEST 12/28/2021
QUIDEL CORPORATION QUIDEL QUICKVUE AT-HOME OTC COVID-19 TES 12/28/2021
QUIDEL CORPORATION QUIDEL QUICKVUE AT-HOME OTC COVID-19 TES 12/28/2021
Unknown Manufacturer COVID-19 RAPID ANTIGEN 12/28/2021
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