AccessGUDID - DEVICE: xTAG® CYP2C19 Kit v3 (00840487100172)

GUDID

Device Identifier (DI) Information

Brand Name: xTAG® CYP2C19 Kit v3
Version or Model: I046B0427
Commercial Distribution Status: In Commercial Distribution
Catalog Number: I046B0427
Company Name: Luminex Molecular Diagnostics, Inc

Primary DI Number: 00840487100172
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 255371916 *Terms of Use

Device Description: The xTAG® CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP450 2C19 gene, located on chromosome 10q24, from genomic DNA extracted from EDTA or citrate anticoagulated whole blood samples.

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?
60519	Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex	A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose or predict gene polymorphisms within the Cytochrome P450 superfamily (CYP450) that are associated with metabolism of xenobiotics/drugs, including warfarin, analgesics and/or anti-depressants, using a multiplex method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NTI	Drug metabolizing enzyme genotyping systems

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131565	000

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 8 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: 1e707d5b-5d67-4ce3-8bc6-b16c152d3823
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 09, 2016