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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device next generation sequencing oncology panel, somatic or germline variant detection system
Definition A next generation sequencing (NGS) oncology panel is a device used for the qualitative detection of germline or somatic variants in one or more cancer-related genes. The device is intended to be used on DNA or RNA isolated from human clinical specimens.
Product CodePQP
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
0 0 0 0 0 0 0 0 0 1 0

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