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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 S055 10/18/2016
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST Roche Molecular Systems, Inc. P060030 S054 09/13/2016
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST Roche Molecular Systems, Inc. P060030 S053 08/18/2016
COBAS AMPLICOR HCV Roche Molecular Systems, Inc. P000012 S056 08/04/2016
COBAS TAQMAN HCV Roche Molecular Systems, Inc. P060030 S052 08/04/2016
COBAS HCV TEST Roche Molecular Systems, Inc. P150015 S003 08/04/2016
COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, ... Roche Molecular Systems, Inc. P000012 S055 05/13/2016
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST Roche Molecular Systems, Inc. P060030 S051 05/13/2016
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST Roche Molecular Systems, Inc. P060030 S050 04/29/2016
COBAS HCV TEST Roche Molecular Systems, Inc. P150015 S002 04/29/2016
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