Ortho™ Confidence Manual System

Basic Information

• Brand Name: Ortho™ Confidence Manual System
• Primary DI: 05060242473067
• Version / Model: 6141123
• Company Name: ALBA BIOSCIENCE LIMITED
• Labeler DUNS: 516536641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-12
• Public Version: 1
• Public Version Date: 2026-03-20
• Public Version Status: New
• Public Device Record Key: 26a7b806-5b2c-411f-a5dd-69d6e75cd370

Device Description

The Ortho™ Confidence Manual System is intended for daily use to evaluate ABO, RhD and antibody screening reagents by manual blood grouping methods.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
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	05060242473067	GS1

Customer Contacts

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