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., Tm Bioscience Corporation and Clinical Micro Sensors.

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
Cleared Jul 24, 2009
VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST
K083294
Nanosphere, Inc.
Pathology · 256d
Cleared Jul 06, 2009
ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8
K090901
Osmetech Molecular Diagnostics
Pathology · 96d
Cleared Mar 13, 2008
INPLEX CF MOLECULAR TEST
K063787
Third Wave Technologies, Inc.
Pathology · 448d
Cleared Sep 07, 2007
CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01
K062028
Celera Diagnostics
Pathology · 416d
Cleared Jun 07, 2006
TAG-IT CYSTIC FIBROSIS KIT
K060627
Tm Bioscience Corporation
Pathology · 90d
Cleared Mar 28, 2006
ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800
K060543
Clinical Micro Sensors, Inc.
Pathology · 27d
Cleared Jan 19, 2006
ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800
K051435
Clinical Micro Sensors
Pathology · 232d
Not Cleared May 09, 2005
TAG-IT CYSTIC FIBROSIS KIT
DEN050004
Tm Bioscience Corporation
Pathology · 34d

About Product Code NUA - Regulatory Context