Ortho™ Confidence Manual System

GUDID 05060242473067

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

ALBA BIOSCIENCE LIMITED

Red blood cell count IVD, control

• Primary Device ID: 05060242473067
• NIH Device Record Key: 26a7b806-5b2c-411f-a5dd-69d6e75cd370
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ortho™ Confidence Manual System
• Version Model Number: 6141123
• Company DUNS: 516536641
• Company Name: ALBA BIOSCIENCE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060242473067 [Primary]

FDA Product Code

• KSF: Kit, Quality Control For Blood Banking Reagents

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-20
• Device Publish Date: 2026-03-12

Devices Manufactured by ALBA BIOSCIENCE LIMITED

• 05060242473067 - Ortho™ Confidence Manual System: 2026-03-20The Ortho™ Confidence Manual System is intended for daily use to evaluate ABO, RhD and antibody screening reagents by manual blood grouping methods.
• 05060242473067 - Ortho™ Confidence Manual System: 2026-03-20 The Ortho™ Confidence Manual System is intended for daily use to evaluate ABO, RhD and antibody screening reagents by manual b
• 05060242472596 - ORTHO® Elution Kit: 2025-12-12 The Ortho® Elution Kit is intended for use in the acid elution of antibodies from intact red blood cells to allow further dete
• 05060242477959 - ALBA Elution Kit: 2023-10-23 The ALBA Elution Kit is intended for use in the acid elution of antibodies from intact red blood cells to allow further detectio
• 10758750006144 - FETALSCREEN™II: 2022-03-31 FETALSCREEN™ is a Qualitative Screening Test for RhD (Rho) positive fetal red blood cells in the maternal circulation.
• 10758750013005 - ORTHOTM Sera Anti-Fya: 2022-03-31 The Anti-Fya reagent (Anti-FY1) is for the qualitative in vitro detection of human Fya positive red blood cells by the indirect
• 10758750013012 - ORTHOTM Sera Anti-Fyb: 2022-03-31 The Anti-Fyb reagent (Anti-FY2) is for the qualitative in vitro detection of human Fyb positive red blood cells by the indirect
• 10758750013029 - ORTHOTM Sera Anti-Jka: 2022-03-31 The Anti-Jka reagent (Anti-JK1) is for the qualitative in vitro detection of human Jka positive red blood cells by the direct ag
• 10758750013036 - ORTHOTM Sera Anti-Jkb: 2022-03-31 The Anti-Jkb reagent (Anti-JK2) is for the qualitative in vitro detection of human Jkb positive red blood cells by the direct ag