NA

Basic Information

• Brand Name: NA
• Primary DI: 04719872781653
• Version / Model: PG-1639A-024
• Company Name: PHARMIGENE, Inc.
• Labeler DUNS: 658637223
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-14
• Public Version: 1
• Public Version Date: 2023-06-22
• Public Version Status: New
• Public Device Record Key: 10d85c6d-b2c9-4a75-871a-16e2b630286a

Device Description

The PG1639 Detection Reagent is used for detection of the VKORC1-1639 (G>A) SNP.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• PM Exempt: Yes
• 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
MVU	Reagents, Specific, Analyte	Pathology	864.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60124	Vitamin K epoxide reductase complex subunit-1 (VKORC1) gene polymorphism IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used to evaluate a clinical specimen to diagnose or predict Vitamin K epoxide reductase complex subunit-1 (VKORC1) gene polymorphisms associated with warfarin metabolism.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719872781653	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – -15 Degrees Celsius