INFINITI® Factor II-V Leiden Amplification Mix

Basic Information

• Brand Name: INFINITI® Factor II-V Leiden Amplification Mix
• Primary DI: 00850009370129
• Version / Model: 01-3050-01
• Catalog Number: 01-3050-01
• Company Name: AUTOGENOMICS, INC
• Labeler DUNS: 027914535
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-23
• Public Version: 1
• Public Version Date: 2019-10-31
• Public Version Status: New
• Public Device Record Key: 7505a50f-5fc9-4612-bf1e-c25063d90c2d

Device Description

Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NSU	Instrumentation for clinical multiplex test systems	Clinical Chemistry	862.2570	2
NPQ	TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR	Hematology	864.7280	2
NPR	TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR	Hematology	864.7280	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850009370129	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K060564	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – -15 Degrees Celsius