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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
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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159 records meeting your search criteria returned- Product Code: QKP Product Problem: Product Quality Problem Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
IHEALTH LABS, INC. / IHEALTH MANUFACTURI IHEALTH COVID-19 ANTIGEN RAPID TEST 06/13/2023
Unknown Manufacturer COVID-19 RAPID TEST 05/03/2023
IHEALTH LABS, INC. / IHEALTH MANUFACTURI COVID-19 TEST 04/18/2023
HEALGEN SCIENTIFIC LLC. CLINITEST RAPID COVID-19 ANTINGEN SELF-T 04/03/2023
HEALGEN SCIENTIFIC LLC. CLINITEST RAPID COVID-19 ANTINGEN SELF-T 04/03/2023
PHASE SCIENTIFIC INTERNATIONAL LIMITED INDICAID HOME COVID TEST 03/15/2023
IHEALTH LABS, INC. / IHEALTH MANUFACTURI IHEALTH COVID-19 ANTIGEN RAPID TEST 02/16/2023
IHEALTH LABS, INC. / IHEALTH MANUFACTURI IHEALTH COVID-19 ANTIGEN RAPID TEST 02/16/2023
QUIDEL CORPORATION QUICKVUE AT-HOME OTC COVID TEST 02/10/2023
QUIDEL CORPORATION QUICKVUE AT-HOME OTC COVID TEST 02/10/2023
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