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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cancer-related germline gene mutation detection system
Definition The germline gene mutation test system is an in vitro diagnostic nucleic acid amplification and detection system for the identification of genetic mutations in DNA extracted from human clinical specimens.
Product CodePJG
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 0 0 0 0 0 0 1 2 1

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