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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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Super Search Devices@FDA
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80 records meeting your search criteria returned- Product Code: QKP Patient Problem: Viral Infection Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
Unknown Manufacturer COVID-19 AT HOME TEST 08/22/2022
ORASURE TECHNOLOGIES, INC. INTELISWAB COVID-19 RAPID TEST 08/15/2022
ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST 08/11/2022
ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST 08/05/2022
HUMASIS CO., LTD. CELLTRION DIATRUST COVID-19 AGHOMETEST 08/05/2022
ACCESS BIO INCORPORATE CARESTART COVID-19 ANTIGEN HOME TEST 07/28/2022
ACCESS BIO INCORPORATE CARESTART COVID-19 ANTIGEN HOME TEST 07/28/2022
ACCESS BIO INCORPORATE ON/GO COVID-19 ANTIGEN SELF-TEST 07/28/2022
Unknown Manufacturer COVID TEST 07/25/2022
Unknown Manufacturer COVID TEST 07/25/2022
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