ORTHO® Elution Kit

GUDID 05060242472596

The Ortho® Elution Kit is intended for use in the acid elution of antibodies from intact red blood cells to allow further detection and/or identification.

ALBA BIOSCIENCE LIMITED

Red cell antibody eluting IVD, kit

• Primary Device ID: 05060242472596
• NIH Device Record Key: 0cae77aa-44ac-4cb9-9f3e-bddac814cfa3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHO® Elution Kit
• Version Model Number: 63244444
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060242472596 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK251265

FDA Product Code

• KSS: Supplies, Blood-Bank

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: 2025-12-12
• Device Publish Date: 2025-12-04

Devices Manufactured by ALBA BIOSCIENCE LIMITED

• 05060242472596 - ORTHO® Elution Kit: 2025-12-12The Ortho® Elution Kit is intended for use in the acid elution of antibodies from intact red blood cells to allow further detection and/or identification.
• 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
• 10758750013043 - ORTHOTM Sera Anti-S: 2022-03-31 The Anti-S reagent (Anti-MNS3) is for the qualitative in vitro detection of human S positive red blood cells by the indirect ant