ALBAclone® Anti-Human Globulin Anti-C3d

Basic Information

• Brand Name: ALBAclone® Anti-Human Globulin Anti-C3d
• Primary DI: 05060242471414
• Version / Model: Z360U
• Company Name: ALBA BIOSCIENCE LIMITED
• Labeler DUNS: 516536641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-16
• Public Version: 4
• Public Version Date: 2022-03-31
• Public Version Status: Update
• Public Device Record Key: 8dbe3e55-86a4-4ba8-a6d3-aae3862ddadb

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
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	05060242471414	GS1

Customer Contacts

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

Storage Conditions

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