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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device somatic gene mutation detection system
Definition The somatic gene mutation detection system is an in vitro diagnostic nucleic acid amplification and real-time detection system for the identification of genetic mutations in dna extracted from human tumor tissues.
Product CodeOWD
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 0 0 0 3 4 10 6 31 21

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 2
Class III 0 0 0 0 0 1 0 0 2 0

Recalls
Manufacturer Recall Class Date Posted
1 Roche Molecular Systems, Inc. II Jul-21-2016
2 Roche Molecular Systems, Inc. II May-26-2016
3 Roche Molecular Systems, Inc. III Jun-26-2015
4 Roche Molecular Systems, Inc. III Mar-25-2015
5 Roche Molecular Systems, Inc. III Nov-02-2012

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