IH-Card AHG Anti-IgG

Basic Information

• Brand Name: IH-Card AHG Anti-IgG
• Primary DI: 07611969964857
• Version / Model: 813422100
• Catalog Number: 813422100
• Company Name: Bio-Rad Medical Diagnostics GmbH
• Labeler DUNS: 312576506
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-20
• Public Version: 3
• Public Version Date: 2021-05-24
• Public Version Status: Update
• Public Device Record Key: eb1a2ed9-2a22-4eeb-be28-623f38bed12b

Device Description

Anti-Human Globulin Anti-IgG; Gel card for use with the IH-system; Card for direct and indirect antiglobulin test; 288 cards of 6 microtubes

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: No
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
45811	Polyspecific antihuman globulin IVD, antibody	One or multiple immunoglobulins capable of binding to all classes of human immunoglobulin antibodies fixed to red blood cells and intended to be used in immunohaematological testing of a clinical specimen to detect red blood cell sensitization by human immunoglobulin, using an agglutination or solid-phase red blood cell adherence method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07611969964857	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Upright position
• Type: Storage Environment Temperature
• Temperature Range: 18 – 25 Degrees Celsius