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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 S060 10/13/2017
Cobas HCV Test Roche Molecular Systems, Inc. P150015 S008 10/13/2017
COBAS AmpliPrep/COBAS TaqMan HCV Test, v 2.0 Roche Molecular Systems, Inc. P060030 S059 09/01/2017
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST Roche Molecular Systems, Inc. P060030 S058 08/11/2017
COBAS TaqMan HCV Test, v2.0, for Use with the High... Roche Molecular Systems, Inc. P060030 S057 08/09/2017
cobas HCV Test Roche Molecular Systems, Inc. P150015 S007 08/09/2017
Roche cobas HCV Roche Molecular Systems, Inc. P150015 S006 06/07/2017
COBAS TaqMan HCV Test v2.0, For Use With High Pure... Roche Molecular Systems, Inc. P060030 S056 05/10/2017
COBAS HCV Roche Molecular Systems, Inc. P150015 S005 12/19/2016
COBAS HCV TEST Roche Molecular Systems, Inc. P150015 S004 10/31/2016
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