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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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AMPLICOR HCV TEST Roche Molecular Systems, Inc. P000010 S023 08/09/2011
COBAS AMPLICOR HCV TEST Roche Molecular Systems, Inc. P000012 S032 08/09/2011
AMPLICOR HCV TEST Roche Molecular Systems, Inc. P000010 S019 08/17/2011
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST Roche Molecular Systems, Inc. P060030 S022 09/22/2011
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST Roche Molecular Systems, Inc. P000012 S034 09/29/2011
AMPLICOR HCV TEST V2.0 & COBAS AMPLICOR HCV TEST V... Roche Molecular Systems, Inc. P000010 S025 10/11/2011
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST V2.0 Roche Molecular Systems, Inc. P000012 S035 10/11/2011
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST Roche Molecular Systems, Inc. P060030 S023 10/11/2011
AMPLICOR HCV TEST V2.0 Roche Molecular Systems, Inc. P000010 S022 12/29/2011
COBAS AMPLICOR HCV TEST, V2.0 Roche Molecular Systems, Inc. P000012 S031 12/29/2011
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