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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 and CO... Roche Molecular Systems, Inc. P060030 S069 09/19/2018
cobas HCV Roche Molecular Systems, Inc. P150015 S020 09/19/2018
COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 and CO... Roche Molecular Systems, Inc. P060030 S068 08/17/2018
cobas HCV Roche Molecular Systems, Inc. P150015 S018 08/17/2018
COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 Roche Molecular Systems, Inc. P060030 S067 07/26/2018
Cobas HCV Roche Molecular Systems, Inc. P150015 S017 07/26/2018
COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 Roche Molecular Systems, Inc. P060030 S066 07/05/2018
cobas HCV Roche Molecular Systems, Inc. P150015 S016 07/05/2018
COBAS TaqMan HCV Test, v2.0, For use with the High... Roche Molecular Systems, Inc. P060030 S065 07/03/2018
cobas HCV Test Roche Molecular Systems, Inc. P150015 S015 07/03/2018
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