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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 13 Results
productcode MZO PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
 
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OraQuick HCV Rapid Antibody Test ORASURE TECHNOLOGIES INC. P080027 S037 10/16/2020
ARCHITECT Anti-HCV, Alinity i Anti-HCV ABBOTT LABORATORIES INC P050042 S044 08/28/2020
ADVIA CENTAUR HCV ReadyPack Reagents and Quality C... SIEMENS HEALTHCARE DIAGNOSTICS P030056 S018 08/25/2020
VITROS Immunodiagnostic Products Anti-HCV Reagent ... Ortho-Clinical Diagnostics, In P010021 S033 08/07/2020
LIAISON XL MUREX HCV Ab DiaSorin Inc. P190011 S002 08/06/2020
ADVIA Centaur HCV, and Atellica HCV SIEMENS HEALTHCARE DIAGNOSTICS P030056 S017 06/21/2020
Alinity i Anti-HCV Reagent Kit ABBOTT LABORATORIES INC P050042 S040 06/05/2020
Alinity i Anti-HCV ABBOTT LABORATORIES INC P050042 S041 05/23/2020
ARCHITECT Anti-HCV ABBOTT LABORATORIES INC P050042 S042 05/23/2020
ARCHITECT Anti-HCV and Alinity i Anti-HCV ABBOTT LABORATORIES INC P050042 S043 04/29/2020
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