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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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productcode MZO PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
 
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LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control ... DiaSorin Inc. P190011 10/18/2019
OraQuick HCV Rapid Antibody Test ORASURE TECHNOLOGIES INC. P080027 S035 09/11/2019
Architect Anti-HCV and Alinity i Anti-HCV ABBOTT LABORATORIES INC P050042 S039 08/13/2019
VITROS Immunodiagnostic Products Anti-HCV Reagent ... Ortho-Clinical Diagnostics, In P010021 S032 06/19/2019
Alinity i Anti-HCV Reagent Kit, Alinity i Anti-HCV... ABBOTT LABORATORIES INC P050042 S034 06/18/2019
Elecsys Anti-HCV Immunoassay ROCHE DIAGNOSTICS CORP. P090007 S020 04/24/2019
Elecsys Anti-HCV Immunoassay ROCHE DIAGNOSTICS CORP. P090008 S021 04/24/2019
Elecsys Anti-HCV Immunoassay ROCHE DIAGNOSTICS CORP. P090009 S018 04/24/2019
Elecsys Anti-HCV II ROCHE DIAGNOSTICS OPERATIONS I P140021 S016 04/24/2019
Atellica IM Hepatitis C (aHCV) Assay SIEMENS HEALTHCARE DIAGNOSTICS P030056 S014 03/08/2019
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