Tag-It Cystic Fibrosis Kit

DEN050004 is the FDA 510(k) clearance record for TAG-IT CYSTIC FIBROSIS KIT, a class II device, cleared for Tm Bioscience Corporation on 2005-05-09 under FDA product code NUA (System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection). FDA's definition for product code NUA reads: "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...". FDA records list 2 510(k) clearances for Tm Bioscience Corporation, from 2005-05-09 to 2006-06-07. As of 2026-09-10, FDA records show no recalls naming DEN050004.