AccessGUDID - DEVICE: INFINITI® Factor II-V Leiden Amplification Mix (00850009370129)

GUDID

Device Identifier (DI) Information

Brand Name: INFINITI® Factor II-V Leiden Amplification Mix
Version or Model: 01-3050-01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 01-3050-01
Company Name: AUTOGENOMICS, INC

Primary DI Number: 00850009370129
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: Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations

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?
59586	Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict inherited thrombophilia, which may be associated with, but not limited to, the prothrombin 20,210 mutation and/or the Factor V Leiden mutation (activated protein C resistance), using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NSU	Instrumentation for clinical multiplex test systems
NPQ	TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR
NPR	TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR

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: 7505a50f-5fc9-4612-bf1e-c25063d90c2d
Public Version Date: March 20, 2024
Public Version Number: 2
DI Record Publish Date: October 23, 2019