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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 mutation detection
Regulation Description Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.
Definition The cftr gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the cftr gene. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (cf), carrier identification, and newborn screening. This device is not intended for stand-alone diagnostic purposes, prenatal diagnostic, pre-implantation or population screening.
Product CodeNUA
Regulation Number 866.5900
Device Class 2


Premarket Reviews
ManufacturerDecision
LUMINEX MOLECULAR DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 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 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Hologic, Inc II Apr-27-2016

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