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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 17 of 17 Results
productcode MZP PMA Number p Decision Date From 1/1/2012 Decision Date To 1/1/2013
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COBAS AMPLIPREP / COBAS TAQMAN HCV TEST Roche Molecular Systems, Inc. P060030 S026 06/29/2012
VERSANT HCV RNA QUALITATIVE ASSAY GEN-PROBE P020011 S005 06/25/2012
COBAS AMPLIPREP / COBAS AMPLICOR HCV V2.0 AND COBA... Roche Molecular Systems, Inc. P000012 S038 06/07/2012
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST AND COBAS TA... Roche Molecular Systems, Inc. P060030 S025 06/07/2012
COBAS TAQMAN HCV TESTS Roche Molecular Systems, Inc. P060030 S021 03/20/2012
AMPLICOR HCV TEST Roche Molecular Systems, Inc. P000010 S024 01/11/2012
COBAS AMPLICOR HCV TEST V2.0, COBAS AMPLIPREP/ COB... Roche Molecular Systems, Inc. P000012 S033 01/11/2012
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