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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 17 Results
productcode MZO PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
 
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VITROS Immunodiagnostic Products Anti-HCV Reagent ... Ortho-Clinical Diagnostics, In P010021 S031 12/17/2018
OraQuick HCV Rapid Antibody Test ORASURE TECHNOLOGIES INC. P080027 S034 12/06/2018
ARCHITECT Anti-HCV (LN 1L79) ABBOTT LABORATORIES INC P050042 S037 11/09/2018
Architect Anti-HCV Regent Kit (100, 500 Test) ABBOTT LABORATORIES INC P050042 S036 11/07/2018
Elecsys ANti-HCV II (100/200 tests) ROCHE DIAGNOSTICS OPERATIONS I P140021 S015 11/06/2018
ARCHITECT Anti-HCV ABBOTT LABORATORIES INC P050042 S035 10/19/2018
Atellica IM Analyzer Hepatitis C (aHCV) SIEMENS HEALTHCARE DIAGNOSTICS P030056 S013 09/11/2018
VITROS Immunodiagnostic Products Anti-HCV Reagent ... Ortho-Clinical Diagnostics, In P010021 S029 07/02/2018
VITROS Immunodiagnostic Products Anti-HCV Reagent ... Ortho-Clinical Diagnostics, In P010021 S030 07/02/2018
Elecsys Anti-HCV Immunoassay ROCHE DIAGNOSTICS CORP. P090008 S020 06/13/2018
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