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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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6 records meeting your search criteria returned- Product Code: QKP Product Problem: Fluid/Blood Leak Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
HEALGEN SCIENTIFIC CLINITEST RAPID COVID-19 ANTIGEN SELF-TE 01/08/2024
Unknown Manufacturer COVID TEST 05/09/2023
SIEMENS HEALTHINEERS /HEALGEN SCIENTIFIC CLINITEST COVID-19 ANTIGEN SELF-TEST 09/30/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 08/08/2022
ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 ANTIGEN SELF TEST 11/03/2021
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD RAPID DETECTION OF SARS-COV-2 VERITOR 08/24/2021
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