ALBAclone Anti-B

Basic Information

• Brand Name: ALBAclone Anti-B
• Primary DI: 05060242471438
• Version / Model: Z015U
• Company Name: ALBA BIOSCIENCE LIMITED
• Labeler DUNS: 516536641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-11-28
• Public Version: 4
• Public Version Date: 2022-03-31
• Public Version Status: Update
• Public Device Record Key: 6ae99c19-acca-49d6-ba39-33c12300211b

Device Description

Blood Grouping Reagent, ALBAclone Anti-B (Murine Monoclonal IgM) for slide and tube techniques.

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
52538	Anti-B red blood cell grouping IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used in testing a clinical specimen for group B [ABO002] red blood cell antigens, using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060242471438	GS1
Package	05060242471254	GS1	Carton	3	In Commercial Distribution
Package	05060242470875	GS1	Carton	10	In Commercial Distribution

Customer Contacts

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