# System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
> **Product code: NUA** · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5900
## Classification
- **FDA Product Code:** NUA
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.5900
- **Review panel:** PA
- **Medical specialty:** Immunology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 12
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NUA)
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