NA

Basic Information

• Brand Name: NA
• Primary DI: 04719872780014
• Version / Model: PG-IC01A-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: 823084fe-9bfb-4adb-a01b-10651d577db2

Device Description

The PGIC01 Detection Reagent is used for amplification of an internal control gene.

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
61280	Killer cell immunoglobulin-like receptor (KIR) genotype/HLA ligand detection IVD, primer	A defined piece of single-stranded nucleic acid which binds to and initiates replication of a target nucleic acid template in an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict one or multiple polymorphisms associated with killer cell immunoglobulin-like receptors (KIR) and/or their HLA associated ligands. KIR genotypes detected may include but are not limited to KIR2DL4, KIR3DL2, and KIR3DP1, associated with immune responses e.g., graft versus host disease, autoimmune disease and acute organ rejection.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719872780014	GS1

Customer Contacts

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

Storage Conditions

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