ALBAcyte A2 Cells

Basic Information

• Brand Name: ALBAcyte A2 Cells
• Primary DI: 05060242471131
• Version / Model: Z406U
• Company Name: ALBA BIOSCIENCE LIMITED
• Labeler DUNS: 516536641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-11-14
• Public Version: 4
• Public Version Date: 2022-03-31
• Public Version Status: Update
• Public Device Record Key: 7707bac2-c1fc-49ec-b366-ce819aca4c8f

Device Description

2-3% Reagent Red Blood Cells for ABO Reverse Grouping, ALBAcyte A2 Cells, for 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
52674	Group A2 Rh (D) negative reagent red blood cell IVD, antigen	A sample of specifically characterized reagent red blood cells intended to be used in testing a clinical specimen due to their classification as blood group A2 Rh(D) negative. These reagent cells are positive for blood group antigen A [ABO001] but negative for blood group antigens A1 [ABO004] and Rh(D) [RH001].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060242471131	GS1

Customer Contacts

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