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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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30 records meeting your search criteria returned- Product Code: QJR Product Problem: Adverse Event Without Identified Device or Use Problem Report Date From: 01/1/2018
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ManufacturerBrand NameDate Report Received
QIAGEN GMBH QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL 01/25/2023
QIAGEN GMBH QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL 12/20/2022
QIAGEN GMBH QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL 12/15/2022
QIAGEN GMBH QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL 12/09/2022
ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW COVID-19 ASSAY 09/27/2022
T2 BIOSYSTEMS, INC T2SARS-COV-2, EUA 05/27/2022
ABBOTT MOLECULAR INC. ABBOTT MOLECULAR, INC. ALINITY M SARS-CO 03/02/2022
Unknown Manufacturer COVID 19 TEST 01/26/2022
Unknown Manufacturer COVID-19 TEST KIT 11/12/2021
Unknown Manufacturer COVID-19 TEST KIT 11/04/2021
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