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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 HCV TEST V2.0 Roche Molecular Systems, Inc. P000012 S047 01/09/2014
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST Roche Molecular Systems, Inc. P060030 S038 01/09/2014
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST Roche Molecular Systems, Inc. P000012 S045 10/09/2013
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST Roche Molecular Systems, Inc. P000012 S046 10/09/2013
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST Roche Molecular Systems, Inc. P060030 S036 10/09/2013
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST Roche Molecular Systems, Inc. P060030 S037 10/09/2013
COBAS AMPLICOR HCV TEST, COBAS AMPLIPREP/COBAS AMP... Roche Molecular Systems, Inc. P000012 S044 09/12/2013
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, COBAS TAQMA... Roche Molecular Systems, Inc. P060030 S035 09/12/2013
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST VERSION 2.0,... Roche Molecular Systems, Inc. P060030 S034 09/06/2013
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST,V2.0,; HIGH ... Roche Molecular Systems, Inc. P060030 S033 08/21/2013
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