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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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productcode MZP PMA Number p Decision Date From 1/1/2009 Decision Date To 1/1/2010
 
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VERSANT HCV RNA 3.0 ASSAY (BDNA) SIEMENS HEALTHCARE DIAGNOSTICS P020022 S009 12/23/2009
COBAS AMPLIPREP / COBAS TAQMAN HCV TEST Roche Molecular Systems, Inc. P060030 S005 10/13/2009
AMPLICOR HCV TEST Roche Molecular Systems, Inc. P000010 S014 07/30/2009
COBAS AMPLICOR HCV TEST/COBAS AMPLIPREP Roche Molecular Systems, Inc. P000012 S021 07/30/2009
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST Roche Molecular Systems, Inc. P060030 S004 07/30/2009
VERSANT HCV RNA QUALITATIVE ASSAY AND THE APTIMA H... GEN-PROBE P020011 S001 05/22/2009
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST Roche Molecular Systems, Inc. P060030 S003 05/22/2009
VERSANT HCV RNA 3.0 ASSAY (BDNA) SIEMENS HEALTHCARE DIAGNOSTICS P020022 S008 05/01/2009
VERSANT HCV RNA 3.0 (BDNA) WITH VERSANT 440 MOLECU... SIEMENS HEALTHCARE DIAGNOSTICS P020022 S007 04/14/2009
AMPLICOR HCV TEST VERSION 2.0 Roche Molecular Systems, Inc. P000010 S013 01/14/2009
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