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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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10 records meeting your search criteria returned- Product Code: QKP Product Problem: Labelling, Instructions for Use or Training Problem Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 TEST 07/06/2022
ACON LABORATORIES, INC. ACON FLOWFLEX COVID-19 ANTIGEN HOME TEST 06/27/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 06/02/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 04/26/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 03/29/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 03/29/2022
Unknown Manufacturer HOME RAPID ANTIGEN TEST 02/24/2022
HUMASIS CO., LTD. CELLTRION DIATRUST COVID-19 AG HOME TEST 02/23/2022
INTRIVO ON/GO COVID-19 ANTIGEN SELF-TEST 01/11/2022
ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ABBOTT BINAXNOW COVID-19 ANTIGEN SELF TE 11/29/2021
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