§ 866.5900. Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.
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/us/cfr/t21/s§ 866.5900·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. 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.
(b)Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: CFTR Gene Mutation Detection System.” See § 866.1(e) for the availability of this guidance document. [70 FR 61738, Oct. 26, 2005]
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§ 866.5900
Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.
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