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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
 

 
 
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500 records meeting your search criteria returned. The results are incomplete - please narrow your search.
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ManufacturerBrand NameDate Report Received
QUIDEL CORPORATION QUIDEL QUICKVUE LFA COVID TEST 12/30/2021
QUIDEL CORPORATION QUIDEL QUICKVUE LFA COVID TEST 12/30/2021
QUIDEL CORPORATION QUIDEL QUICKVUE LFA COVID TEST 12/30/2021
ABBOTT BINAXNOW COVID-19 AG CARD HOME TEST 12/30/2021
ELLUME LIMITED ELLUME COVID-19 HOME TEST 12/30/2021
QUIDEL CORP. QUICKVUE AT-HOME OTC COVID-19 TEST 12/30/2021
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 12/30/2021
ABBOTT DIAGNOSTICS SCARBOROUGH, INC BINAXNOW COVID-19 ANTIGEN SELF TEST 12/30/2021
ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW¿ COVID-19 ANTIGEN SELF TEST OTC 12/30/2021
ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 ANTIGEN SELF TEST OTC 12/30/2021
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