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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 35 Results
productcode MZP PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
 
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COBAS HCV TEST Roche Molecular Systems, Inc. P150015 S036 12/18/2019
Aptima HCV Quant Dx Assay HOLOGIC, INC. P160023 S015 12/16/2019
Cobas HCV Roche Molecular Systems, Inc. P150015 S032 12/11/2019
COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 Roche Molecular Systems, Inc. P060030 S081 11/05/2019
Cobas TaqMan HCV Test, v2.0, for Use with the High... Roche Molecular Systems, Inc. P060030 S080 10/10/2019
cobas HCV Test Roche Molecular Systems, Inc. P150015 S035 10/10/2019
cobas HCV Roche Molecular Systems, Inc. P150015 S034 09/26/2019
COBAS AmpliPrep/COBAS TaqMan HCV Test V2.0 Roche Molecular Systems, Inc. P060030 S079 09/12/2019
cobas HCV Roche Molecular Systems, Inc. P150015 S033 09/04/2019
cobas AmpliPrep/cobas TaqMan HCV Test, v2 Roche Molecular Systems, Inc. P060030 S078 08/13/2019
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