Anti-Human Globulin Anti-IgG,-C3d, polyspecific - Green

Basic Information

• Brand Name: Anti-Human Globulin Anti-IgG,-C3d, polyspecific - Green
• Primary DI: 23661562105469
• Version / Model: 210546
• Catalog Number: 210546
• Company Name: DIAGAST
• Labeler DUNS: 381527001
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2018-05-01
• Public Version: 3
• Public Version Date: 2021-05-24
• Public Version Status: Update
• Public Device Record Key: 0287a2a8-8603-4b64-97d6-fe678bab1cb2

Device Description

Anti-Human Globulin Anti-IgG,-C3d (Murine Monoclonal) (18833+18896+12011D10) is intended for use in the direct antiglobulin test to detect the in vivo coating on human red blood cells with IgG and/or C3d components. In addition to recognizing IgG antibodies and the complement fragment C3d, Anti Human Globulin Anti-IgG, C3d is able to recognize IgM antibodies on the surface of red blood cells since IgM antibodies always fix complement

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: Yes
• 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
Primary	23661562105469	GS1
Unit of Use	13661562105462	GS1

Customer Contacts

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

Storage Conditions

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