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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
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

 
 
9 records meeting your search criteria returned- Product Code: QKP Product Problem: Patient Device Interaction Problem Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
Unknown Manufacturer COVID TEST 05/09/2023
Unknown Manufacturer COVID 19 TEST KIT 02/21/2023
ABBOTT BINAX NOW COVID HOME ANTIGEN TEST 09/21/2022
ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST 04/07/2022
ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST 04/07/2022
ABBOTT BINAXNOW 04/04/2022
QUIDEL CORP. QUIDEL QUICKVUE ANTIGEN TEST 12/03/2021
QUIDEL CORPORATION QUIDEL SOFIA NASAL SWAB 11/15/2021
ABBOTT DIAGNOSTICS SCABOROUGH BINAXNOW COVID-19 AG CARD 11/11/2021
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