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U.S. Department of Health and Human Services

Manufacturer and User Facility Device Experience (MAUDE)

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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
ELLUME USA LLC. ELLUME COVID-19 HOME TEST 08/01/2022
Unknown Manufacturer COVID RAPID TEST 07/28/2022
QUIDEL CORPORATION QUICKVUE AT-HOME OTC COVID 19 TEST 07/22/2022
QUIDEL CORPORATION QUICKVUE AT-HOME OTC COVID 19 TEST 07/22/2022
CELTRION DIATRUST 07/19/2022
QUIDEL CORP. QUICK VUE AT HOME OTC COVID 19 TEST 07/15/2022
IHEALTH IHEALTH COVID-19 ANTIGEN RAPID TEST 07/13/2022
IHEALTH IHEALTH COVID-19 ANTIGEN RAPID TEST 07/13/2022
ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST 07/13/2022
SD BIOSENSOR, INC. COVID-19 ANTIGEN TEST 06/27/2022
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