ALBAcyte IgG Sensitized Red Blood Cells II

Basic Information

• Brand Name: ALBAcyte IgG Sensitized Red Blood Cells II
• Primary DI: 05060242472329
• Version / Model: Z443U
• Company Name: ALBA BIOSCIENCE LIMITED
• Labeler DUNS: 516536641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-10
• Public Version: 3
• Public Version Date: 2022-03-31
• Public Version Status: Update
• Public Device Record Key: 7ccf28d2-3526-4fbb-a105-fde112498342

Device Description

These IgG Sensitized Red Blood Cells are for the control of the Indirect Antiglobulin Test (IAT) and Direct Antiglobulin Test (DAT).

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	864.9650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52716	Immunoglobulin-sensitized reagent red blood cell IVD, control	A sample of reagent red blood cells sensitized to or coated with antibodies [e.g., immunoglobulin G (IgG) or immunoglobulin M (IgM)] intended to be used to verify the performance of an assay (e.g., Coombs control) for evaluation of a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05060242472336	GS1		1	In Commercial Distribution
Primary	05060242472329	GS1
Package	05060242472343	GS1		3	In Commercial Distribution
Package	05060242472350	GS1		10	In Commercial Distribution

Customer Contacts

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

Storage Conditions

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