ALBAcyte Orr cells

Basic Information

• Brand Name: ALBAcyte Orr cells
• Primary DI: 05060242471155
• Version / Model: Z421U
• Company Name: ALBA BIOSCIENCE LIMITED
• Labeler DUNS: 516536641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-01-08
• Public Version: 4
• Public Version Date: 2022-03-31
• Public Version Status: Update
• Public Device Record Key: 2f55c14d-e792-4734-8101-92958fae087c

Device Description

2-3% Reagent Red Blood Cells for ABO Reverse Grouping, ALBAcyte Orr 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
52684	Group O 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 O Rh (D) negative. These reagent cells are negative for blood group antigens A [ABO001], B [ABO002] and AB [ABO003], and negative for blood group antigen Rh (D) [RH001].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060242471155	GS1

Customer Contacts

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