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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 v2.0 Roche Molecular Systems, Inc. P060030 S081 11/05/2019
COBAS AmpliPrep/COBAS TaqMan HCV Test V2.0 Roche Molecular Systems, Inc. P060030 S079 09/12/2019
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST V2.0 Roche Molecular Systems, Inc. P060030 S047 05/08/2015
COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 Roche Molecular Systems, Inc. P060030 S077 06/13/2019
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST AND COBAS TA... Roche Molecular Systems, Inc. P060030 S025 06/07/2012
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST AND COBAS TA... Roche Molecular Systems, Inc. P060030 S020 12/29/2011
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST Roche Molecular Systems, Inc. P060030 S016 07/12/2012
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST Roche Molecular Systems, Inc. P060030 S018 05/05/2011
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST Roche Molecular Systems, Inc. P060030 S037 10/09/2013
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST Roche Molecular Systems, Inc. P060030 S036 10/09/2013
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