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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 AMPLIPREP/COBAS TAQMAN HCV TEST AND COBAS TA... Roche Molecular Systems, Inc. P060030 S020 12/29/2011
AMPLICOR HCV TEST Roche Molecular Systems, Inc. P000010 S024 01/11/2012
COBAS AMPLICOR HCV TEST V2.0, COBAS AMPLIPREP/ COB... Roche Molecular Systems, Inc. P000012 S033 01/11/2012
COBAS TAQMAN HCV TESTS Roche Molecular Systems, Inc. P060030 S021 03/20/2012
COBAS AMPLIPREP / COBAS AMPLICOR HCV V2.0 AND COBA... Roche Molecular Systems, Inc. P000012 S038 06/07/2012
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST AND COBAS TA... Roche Molecular Systems, Inc. P060030 S025 06/07/2012
COBAS AMPLIPREP / COBAS TAQMAN HCV TEST Roche Molecular Systems, Inc. P060030 S026 06/29/2012
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST Roche Molecular Systems, Inc. P060030 S016 07/12/2012
COBAS AMPLICOR HCV TEST, V2.0, COBAS AMPLIPREP/COB... Roche Molecular Systems, Inc. P000012 S039 09/14/2012
COBAS AMPLIPREP/ COBAS TAQMAN HCV TEST Roche Molecular Systems, Inc. P060030 S028 09/14/2012
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