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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 HCV TEST Roche Molecular Systems, Inc. P150015 S026 05/08/2019
cobas HCV Roche Molecular Systems, Inc. P150015 S025 05/03/2019
cobas HCV Test Roche Molecular Systems, Inc. P150015 S024 04/25/2019
COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 Roche Molecular Systems, Inc. P060030 S073 04/10/2019
COBAS AmpliPrep/COBAS TaqMan HCV Test Roche Molecular Systems, Inc. P060030 S072 01/02/2019
cobas HCV Roche Molecular Systems, Inc. P150015 S023 01/02/2019
COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 and CO... Roche Molecular Systems, Inc. P060030 S071 12/13/2018
cobas HCV Roche Molecular Systems, Inc. P150015 S022 12/13/2018
COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 and CO... Roche Molecular Systems, Inc. P060030 S070 12/07/2018
cobas HCV Roche Molecular Systems, Inc. P150015 S021 12/07/2018
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