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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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500 records meeting your search criteria returned. The results are incomplete - please narrow your search.
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ManufacturerBrand NameDate Report Received
SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT SARS-COV-2 IGG (SCOVG) 12/30/2021
SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT SARS-COV-2 IGG (SCOVG) 12/30/2021
Unknown Manufacturer CORONACHECK COVID-19 IGG/IGM RAPID TEST 12/27/2021
ABBOTT IRELAND SARS-COV-2-IGG REAGENT KIT 12/27/2021
ABBOTT IRELAND SARS-COV-2 IGG II QUANT REAGENT KIT 12/20/2021
BECKMAN COULTER ACCESS SARS-COV-2 IGG (1ST IS) 12/17/2021
BECKMAN COULTER ACCESS SARS-COV-2 IGG 12/16/2021
BECKMAN COULTER SARS-COV-2 IGG 12/10/2021
ABBOTT IRELAND SARS-COV-2 IGG II QUANT REAGENT KIT 12/07/2021
ABBOTT IRELAND SARS-COV-2 IGG 12/06/2021
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