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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, mutations & variants panel sequencing detection
Regulation Description Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.
Definition The CFTR gene mutation detection system is used to simultaneously detect and identify a specified panel of mutations and variants in the CFTR gene using sequencing methods. It is intended for carrier screening, as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), and as an initial test to aid in the diagnosis of individuals with suspected CF. It is not intended for stand-alone diagnostic purposes, prenatal diagnostic, or pre-implantation screening.
Product CodePFR
Regulation Number 866.5900
Device Class 2

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