The xTAG® Cystic Fibrosis 39 Kit v2 is a device used to simultaneously detect and identify a panel of mutations and variants in the Cystic Fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens.

The xTAG® Cystic Fibrosis 39 Kit v2 is a device used to simultaneously detect and identify a panel of mutations and variants in the Cystic Fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens.
xTAG® Cystic Fibrosis (CFTR) 39 kit v2 - I027C0231

A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict one or multiple mutations associated with the inborn genetic disorder cystic fibrosis due to mutation in the cystic fibrosis conductance regulator (CFTR) gene, using a multiplex method.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NUA

Device Name: System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

Device Class: 2

Physical State: Multiplex qualitative amplification based detection system. Should not include devices which use sequencing based detection methods.

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.

Submission Type ID: 1

Review Panel: PA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Uses multiplex polymerase chain reaction to amplify specific DNA variants located on the CFTR gene using non-sequencing based methods.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Human peripheral whole blood or clinical samples.

Regulation Number: 866.5900

Third Party Flag: N

Medical Specialty: IM

Device Id: 00840487100141

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A