NUA · Class II · 21 CFR 866.5900

FDA Product Code NUA: System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

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.

Leading manufacturers include Luminex Molecular Diagnostics, Inc..

12
Total
11
Cleared
186d
Avg days
2005
Since

FDA 510(k) Cleared System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection Devices (Product Code NUA)

12 devices
1–12 of 12
Cleared Dec 15, 2016
xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR
K163336
Luminex Molecular Diagnostics, Inc.
Medical Genetics · 17d
Cleared Dec 15, 2016
xTAG Cystic Fibrosis 39 Kit v2
K163347
Luminex Molecular Diagnostics, Inc.
Medical Genetics · 17d
Cleared Dec 11, 2009
XTAG CF60 KIT V2
K083845
Luminex Molecular Diagnostics, Inc.
Pathology · 352d
Cleared Sep 01, 2009
XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267
K083846
Luminex Molecular Diagnostics, Inc.
Pathology · 251d

About Product Code NUA - Regulatory Context