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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, cystic fibrosis transmembrane conductance regulator gene, variant gene sequence detection
Regulation Description Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.
Definition The CFTR gene variant detection system is used to sequence specified regions of the CFTR gene to detect gene variants. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), those with atypical or non-classic presentation of CF, or when other mutation panels have failed to identify both causative mutations. It is not intended for screening (carrier, newborn, population, or pre-implantation), prenatal diagnostic, or used for stand-alone diagnostic purposes
Product CodePFS
Regulation Number 866.5900
Device Class 2

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 1 0 0
Class III 0 0 0 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Illumina Inc II Dec-23-2014
2 Illumina Inc III Dec-23-2014

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