AlbaQ-Chek®

Basic Information

• Brand Name: AlbaQ-Chek®
• Primary DI: 05060242470943
• Version / Model: Z498
• Company Name: ALBA BIOSCIENCE LIMITED
• Labeler DUNS: 516536641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-29
• Public Version: 4
• Public Version Date: 2022-03-31
• Public Version Status: Update
• Public Device Record Key: 4f8caf8a-e49c-4a4f-bd20-d1808898425b

Device Description

AlbaQ-Chek® is intended for use as ABO, RhD and antibody screening controls for automated/semi-automated blood grouping systems using column agglutination techniques.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• 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
55868	Red blood cell count IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of red blood cell (erythrocyte) count and/or the calculation of intermediate red cell parameters in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060242470943	GS1

Customer Contacts

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