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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 8 of 8 Results
productcode MZO PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
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PMA
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ARCHITECT Anti-HCV / Alinity i Anti-HCV ABBOTT LABORATORIES INC P050042 S047 12/15/2021
ARCHITECT Anti-HCV (LN 1L79) ABBOTT LABORATORIES INC P050042 S046 12/06/2021
LIAISON XL MUREX HCV Ab, LIAISON XL MUREX Control... DiaSorin Inc. P190011 S004 08/10/2021
Atellica IM Hepatitis C (aHCV) Assay SIEMENS HEALTHCARE DIAGNOSTICS P030056 S020 04/27/2021
ARCHITECT Anti-HCV Reagent Kit, Alinity i Anti-HCV... ABBOTT LABORATORIES INC P050042 S045 04/22/2021
OraQuick HCV Rapid Antibody Test ORASURE TECHNOLOGIES INC. P080027 S039 04/20/2021
ADVIA Centaur HCV ReadyPack Reagents, Atellica IM ... SIEMENS HEALTHCARE DIAGNOSTICS P030056 S019 03/11/2021
OraQuick HCV Rapid Antibody Test ORASURE TECHNOLOGIES INC. P080027 S038 02/25/2021
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