Anti-Human Globulin Anti-C3d

Basic Information

• Brand Name: Anti-Human Globulin Anti-C3d
• Primary DI: 23661562105483
• Version / Model: 210548
• Catalog Number: 210548
• 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: 2
• Public Version Date: 2020-10-21
• Public Version Status: Update
• Public Device Record Key: b798d266-81e5-4860-8bc9-eed10e4ef648

Device Description

Anti-Human Globulin Anti-C3d (Murine Monoclonal) (12011D10) is intended for use in the direct antiglobulin test to detect the in vivo coating of human red blood cells with C3d components. Anti-Human Globulin Anti-C3d only recognizes the complement fragment and, consequently, cannot react with component C4.

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
52721	Monospecific anti-complement component C3b/C3d (anti-C3b/anti-C3d) IVD, antibody	One or multiple immunoglobulins capable of binding to C3b and/or C3d complement components fixed to red blood cells, and intended to be used in immunohaematological testing of a clinical specimen to detect red blood cell sensitization by complement C3b and/or C3d, using an agglutination technique.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	23661562105483	GS1
Unit of Use	13661562105486	GS1

Customer Contacts

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

Storage Conditions

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