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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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8 records meeting your search criteria returned- Product Code: QKP Product Problem: Device Ingredient or Reagent 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
SIEMENS / HEALGEN SCIENTIFIC LLC. CLINITEST RAPID COVID-19 ANTIGEN SELF-TE 06/06/2023
IHEALTH MANUFACTURING INC. IHEALTH COID-19 ANTIGEN RAPID TEST 05/02/2023
BECTON, DICKINSON & CO. (SPARKS) BD VERITOR ¿ AT-HOME COVID-19 TEST 02/27/2023
QUIDEL CORPORATION QUIDEL QUICKVUE AT-HOME OTC COVID-19 TES 02/23/2023
ACCESS BIO INCORPORATE ON/GO COVID-19 ANTIGEN SELF-TEST 11/30/2022
ABBOTT LABORATORIES BINAXNOW 05/26/2021
BECTON, DICKINSON & CO. (SPARKS) BD RAPID DETECTION OF SARS-COV-2 VERITOR 04/08/2021
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