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System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

FDA product code NUA · 11 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.5900
Review panel
PA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2006-01-19 – 2016-12-15

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.

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