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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 12 Results
productcode MZP PMA Number p Decision Date From 1/1/2015 Decision Date To 1/1/2016
 
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COBAS AMPLICOR HCV TEST VERSION 2.0 Roche Molecular Systems, Inc. P000012 S054 10/15/2015
COBAS HCV TEST Roche Molecular Systems, Inc. P150015 10/14/2015
ABBOTT REALTIME HCV ABBOTT MOLECULAR, INC. P100017 S014 10/09/2015
APTIMA HCV RNA QUALITATIVE ASSAY GEN-PROBE P020011 S008 05/08/2015
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST V2.0 Roche Molecular Systems, Inc. P060030 S047 05/08/2015
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0 Roche Molecular Systems, Inc. P060030 S045 05/01/2015
ABBOTT REALTIME HCV ASSAY ABBOTT MOLECULAR, INC. P100017 S012 04/23/2015
COBAS AMPLICOR HCV TEST , VERSION 2.0 Roche Molecular Systems, Inc. P000012 S053 04/09/2015
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, COBAS TAQMA... Roche Molecular Systems, Inc. P060030 S046 04/09/2015
COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, VERSI... Roche Molecular Systems, Inc. P000012 S052 01/15/2015
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