AccessGUDID - DEVICE: NA (04719872782193)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: PG-0681A-024
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PHARMIGENE, Inc.

Primary DI Number: 04719872782193
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 658637223 *Terms of Use

Device Description: The PG0681 Detection Reagent is used for detection of the CYP2C19*2 (c.681 G>A) SNP.

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
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?
60141	Cytochrome P450 (CYP450) gene polymorphism IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVU	Reagents, Specific, Analyte

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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 -25 and -15 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4ccdda74-fdaf-4ab3-820f-5ad21f52ef19
Public Version Date: June 22, 2023
Public Version Number: 1
DI Record Publish Date: June 14, 2023