Ortho™ BioClone™ PLUS Anti-Human Globulin IgG

Basic Information

• Brand Name: Ortho™ BioClone™ PLUS Anti-Human Globulin IgG
• Primary DI: 05060242472817
• Version / Model: 6141130
• Company Name: ALBA BIOSCIENCE LIMITED
• Labeler DUNS: 516536641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-10
• Public Version: 1
• Public Version Date: 2026-04-20
• Public Version Status: New
• Public Device Record Key: a463dd27-fe08-4b6a-bdab-38c1db51eb2b

Device Description

Anti-Human Globulin Anti-IgG is intended for use in the direct antiglobulin test to detect the in vivo coating of human red blood cells with IgG. Anti-Human Globulin Anti-IgG is intended for use in the indirect antiglobulin test to detect the in vitro coating of human red blood cells with IgG.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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
46948	Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody	One or multiple immunoglobulins capable of binding to human antibodies from immunoglobulin class G (IgG) that are fixed to red blood cell antigens. This immunoglobulin, known as monospecific immunoglobulin G antihuman globulin (IgG AHG) is intended to be used in immunohaematological testing of a clinical specimen to detect red blood cell sensitization by human IgG, 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
Package	05060242472848	GS1		10	In Commercial Distribution
Primary	05060242472817	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius