ALBAcheck BGS Reagent Control for Anti-D

Basic Information

• Brand Name: ALBAcheck BGS Reagent Control for Anti-D
• Primary DI: 05060242471513
• Version / Model: Z271U
• Company Name: ALBA BIOSCIENCE LIMITED
• Labeler DUNS: 516536641
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-11-28
• Public Version: 9
• Public Version Date: 2022-03-31
• Public Version Status: Update
• Public Device Record Key: f4f42f2a-bc15-441a-a385-440b7693f739
• Distribution End Date: 2020-06-18

Device Description

ALBAcheck BGS Reagent Control for Anti-D.

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

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
52705	Antisera matrix (non-reactive) IVD, control	A material consisting of antisera matrix but containing no active immunoglobulins that is intended be used as a negative control to verify the performance of an assay when testing a clinical specimen for red blood cell antigens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060242471513	GS1
Package	05060242471070	GS1	Carton	10	Not in Commercial Distribution	2020-06-18

Customer Contacts

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