AccessGUDID - DEVICE: xTAG® Cystic Fibrosis (CFTR) 39 kit v2 (00840487100141)

GUDID

Device Identifier (DI) Information

Brand Name: xTAG® Cystic Fibrosis (CFTR) 39 kit v2
Version or Model: I027C0231
Commercial Distribution Status: In Commercial Distribution
Catalog Number: I027C0231
Company Name: Luminex Molecular Diagnostics, Inc

Primary DI Number: 00840487100141
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 255371916 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
59365	Cystic fibrosis IVD, kit, multiplex	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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NUA	System, cystic fibrosis transmembrane conductance regulator, gene mutation detection

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 6 Degrees Celsius
Storage Environment Temperature: between -25 and -15 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9943eb4c-1c23-4501-9e07-b92f24a61988
Public Version Date: October 28, 2019
Public Version Number: 4
DI Record Publish Date: September 09, 2016