AccessGUDID - DEVICE: INFINITI® Warfarin Amplification Mix (00850009370181)

GUDID

Device Identifier (DI) Information

Brand Name: INFINITI® Warfarin Amplification Mix
Version or Model: 03-3140-01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 03-3140-01
Company Name: AUTOGENOMICS, INC

Primary DI Number: 00850009370181
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: CYP450 2C9 drug metabolizing enzyme and VKORC1 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?
63207	Anticoagulant-resistance multiple genetic risk factor IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to predict or monitor the genetic predisposition of a patient exhibiting resistance to anticoagulation agents based on multiple genetic markers which may include the Cytochrome P450 superfamily (CYP450) and Vitamin K epoxide reductase complex subunit-1 (VKORC1) gene polymorphisms, using a nucleic acid technique (NAT). It is used to aid therapy management of patients with thromboembolic disease typically treated with coumarin derivatives (e.g., warfarin).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ODV	Vitamin k epoxide reductase complex subunit one (vkorc1) genotyping system
ODW	Cytochrome P450 2C9 (Cyp450 2c9) drug metabolizing enzyme genotyping system

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: b0ba6f17-9227-4205-a998-f20674710a89
Public Version Date: March 20, 2024
Public Version Number: 2
DI Record Publish Date: October 23, 2019