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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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83 records meeting your search criteria returned- Product Code: QKP Patient Problem: Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available Report Date From: 01/1/2019

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ManufacturerBrand NameDate Report Received
HEALGEN SCIENTIFIC LLC. CLINITEST RAPID COVID-19 ANTINGEN SELF-T 04/03/2023
PHASE SCIENTIFIC INTERNATIONAL LIMITED INDICAID HOME COVID TEST 03/15/2023
ORASURE TECHNOLOGIES, INC. INTELISWAB COVID-19 RAPID TEST 03/10/2023
ORASURE TECHNOLOGIES, INC. INTELISWAB COVID-19 RAPID TEST 02/09/2023
QUIDEL CORPORATION QUICKVUE 02/08/2023
QUIDEL CORPORATION QUICKVUE 02/08/2023
ORASURE TECHNOLOGIES, INC. INTELISWAB COVID-19 RAPID TEST 01/12/2023
ORASURE TECHNOLOGIES, INC. INTELISWAB COVID-19 RAPID TEST 01/12/2023
ORASURE TECHNOLIGIES, INC. INTELISWAB COVID-19 RAPID TEST 01/11/2023
BAJA COSMETICS QUIDEL QUICKVUE AT-HOME OTC COVID-19 TES 01/09/2023
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