Anti-human Globulin Anti-IgG, -C3d Polyspecific Rabbit/Murine Monoclonal

Basic Information

• Brand Name: Anti-human Globulin Anti-IgG, -C3d Polyspecific Rabbit/Murine Monoclonal
• Primary DI: 05060242472367
• Version / Model: Z351U
• Company Name: ALBA BIOSCIENCE LIMITED
• Labeler DUNS: 516536641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-20
• Public Version: 3
• Public Version Date: 2022-03-31
• Public Version Status: Update
• Public Device Record Key: 0bf6d6b2-f808-47fa-821b-c30f33e8e667

Device Description

Anti-Human Globulin Anti-IgG,-C3d; Polyspecific is intended for use in the direct antiglobulin test to detect the in vivo coating of human red blood cells with IgG and/or C3b and/or C3d components. Anti-Human Globulin Anti-IgG,-C3d; Polyspecific is intended for use in the indirect antiglobulin test to detect the in vitro coating of human red blood cells with IgG and/or C3b and/or C3d components.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
52731	Polyspecific antihuman globulin/complement IVD, antibody	One or multiple immunoglobulins capable of binding to all classes of human immunoglobulin antibodies and/or complement components when fixed to red blood cells. This solution is intended to be used in immunohaematological testing of a clinical specimen to detect red blood cell sensitization by human immunoglobulin and/or complement components, 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	05060242472374	GS1		1	In Commercial Distribution
Primary	05060242472367	GS1
Package	05060242472381	GS1		3	In Commercial Distribution
Package	05060242472398	GS1		10	In Commercial Distribution

Customer Contacts

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

Storage Conditions

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