510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NUAClass II

System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

21 CFR 866.5900 / Immunology
FDA source (opens on fda.gov)

NUA is the FDA product code for System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection, a class II device type, regulated under 21 CFR 866.5900. FDA's definition for this code 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 cystic fibrosis (cf), carrier identification, and newborn screening. This device...". As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
NUA
Device name
System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
FDA definition
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.
Regulation
21 CFR 866.5900
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
2

Clearances, product code NUA

By decision year
12 clearances under product code NUA with a decision year between 2005 and 2016, 2009 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code NUA by decision year
YearClearances
20051
20063
20071
20081
20094
20162

Applicants with the most clearances

Product code NUA
Applicants holding the most 510(k) clearances under product code NUA
ApplicantClearances
Luminex Molecular Diagnostics Inc4
Clinical Micro Sensors, Inc.2
Tm Bioscience Corporation2
Celera Diagnostics1
Luminex Corporation1
Osmetech Molecular Diagnostics1
Third Wave Technologies, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code