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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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PMA
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Cobas AmpliPrep/Cobas TaqMan HCV Test, v2.0 Roche Molecular Systems, Inc. P060030 S063 05/15/2018
Cobas AmpliPrep/Cobas TaqMan HCV Test, v2.0 Roche Molecular Systems, Inc. P060030 S064 05/04/2018
Cobas HCV Roche Molecular Systems, Inc. P150015 S014 05/04/2018
Cobas AmpliPrep/Cobas TaqMan HCV Test, v.20 Roche Molecular Systems, Inc. P060030 S062 03/26/2018
Cobas HCV Test Roche Molecular Systems, Inc. P150015 S013 03/26/2018
Cobas HCV Test Roche Molecular Systems, Inc. P150015 S012 02/20/2018
Cobas TaqMan HCV Test, v2.0 Roche Molecular Systems, Inc. P060030 S061 12/20/2017
Cobas HCV Roche Molecular Systems, Inc. P150015 S011 12/11/2017
Cobas HCV Roche Molecular Systems, Inc. P150015 S010 11/13/2017
cobas HCV Test Roche Molecular Systems, Inc. P150015 S009 10/26/2017
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