NUA

System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

Product code

NUA

Device name

System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

Device class

Class 2

21 CFR

21 CFR 866.5900

Medical specialty

Immunology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

12 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).