INFINITI® CYP2C19 BioFilmChip® Microarray Magazine

Basic Information

• Brand Name: INFINITI® CYP2C19 BioFilmChip® Microarray Magazine
• Primary DI: 00850009370136
• Version / Model: 03-1220-01
• Catalog Number: 03-1220-01
• 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: 1ec40282-446e-4288-9ebe-fd362f61911b

Device Description

CYP2C19 drug metabolyzing enzyme genotyping system

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
NTI	Drug metabolizing enzyme genotyping systems	Clinical Toxicology	862.3360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850009370136	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K101683	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 8 Degrees Celsius