ALBAcyte Expanded Rh Negative Antibody Screen

Basic Information

• Brand Name: ALBAcyte Expanded Rh Negative Antibody Screen
• Primary DI: 05060242471377
• Version / Model: Z464U
• 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: fc24aab9-c9c6-45d2-b156-86f06ddafc6a

Device Description

Reagent Red Blood Cells, ALBAcyte Expanded Rh Negative Antibody Screen for tube techniques, 2-3% suspension.

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
52543	Antibody identification panel reagent red blood cell IVD, kit, agglutination	A collection of four or more specifically characterized reagent red blood cells that are supplied together as a set and intended to be used to determine the exact specificity of antibodies to red blood cell antigens present in a clinical specimen, using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060242471377	GS1

Customer Contacts

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