AccessGUDID - DEVICE: INFINITI® CYP2C19 Amplification Mix (00850009370150)

GUDID

Device Identifier (DI) Information

Brand Name: INFINITI® CYP2C19 Amplification Mix
Version or Model: 03-3220-01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 03-3220-01
Company Name: AUTOGENOMICS, INC

Primary DI Number: 00850009370150
Issuing Agency: GS1
Commercial Distribution End Date: March 19, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 027914535 *Terms of Use

Device Description: CYP2C19 drug metabolyzing enzyme genotyping system

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):	Yes
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NTI	Drug metabolizing enzyme genotyping systems
NSU	Instrumentation for clinical multiplex test systems

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 -30 and -15 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b6bbbb14-9d6e-459f-8d00-97fb9c3aa8f0
Public Version Date: March 20, 2024
Public Version Number: 2
DI Record Publish Date: October 23, 2019