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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/COBAS AMPLIPREP/COBA... Roche Molecular Systems, Inc. P000012 S036 09/18/2012
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST/COBAS TAQMAN... Roche Molecular Systems, Inc. P060030 S024 09/18/2012
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2... Roche Molecular Systems, Inc. P000012 S040 10/10/2012
COBAS AMPLIPREP/COBAS TAQMAN HCV V2.0 TEST FOR USE... Roche Molecular Systems, Inc. P060030 S029 10/10/2012
COBAS TAQMAN HCV TEST V2.0 FOR USE WITH THE HIGH P... Roche Molecular Systems, Inc. P060030 S030 01/02/2013
COBAS AMPLIPREP / COBAS TAQMAN HCV TEST Roche Molecular Systems, Inc. P060030 S031 02/11/2013
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0 Roche Molecular Systems, Inc. P060030 S027 02/14/2013
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, V2.0 Roche Molecular Systems, Inc. P000012 S041 06/06/2013
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST V2.0 Roche Molecular Systems, Inc. P060030 S032 06/06/2013
COBAS AMPLICOR HCV TEST V2.0,COBAS AMPLIPREP/COBAS... Roche Molecular Systems, Inc. P000012 S042 06/07/2013
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