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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Applicant Roche Molecular Systems, Inc. productcode MZP Decision Date To 05/01/2024
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COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, VERSI... Roche Molecular Systems, Inc. P000012 S051 01/14/2015
COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE S... Roche Molecular Systems, Inc. P060030 S044 01/14/2015
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2... Roche Molecular Systems, Inc. P000012 S050 12/04/2014
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0 Roche Molecular Systems, Inc. P060030 S043 08/22/2014
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST Roche Molecular Systems, Inc. P000012 S049 04/28/2014
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST Roche Molecular Systems, Inc. P060030 S042 04/28/2014
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, V2.0 Roche Molecular Systems, Inc. P000012 S048 04/04/2014
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0 Roche Molecular Systems, Inc. P060030 S041 04/04/2014
COBAS AMPLIPREP/COMBAS TAQMAN HCV TEST V2.0 Roche Molecular Systems, Inc. P060030 S040 03/18/2014
COBAS AMPLIPREP/ COBAS TAQMAN HCV TEST, V2.0 Roche Molecular Systems, Inc. P060030 S039 03/04/2014
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