xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR

K163336 is the FDA 510(k) clearance record for xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR, a class II device, cleared for Luminex Molecular Diagnostics, Inc. on 2016-12-15 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 26 510(k) clearances for Luminex Molecular Diagnostics, Inc., from 2008-01-03 to 2024-10-02. As of 2026-09-10, FDA records show no recalls naming K163336.