ORTHO® Elution Kit

Basic Information

• Brand Name: ORTHO® Elution Kit
• Primary DI: 05060242472596
• Version / Model: 63244444
• Company Name: ALBA BIOSCIENCE LIMITED
• Labeler DUNS: 516536641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-04
• Public Version: 1
• Public Version Date: 2025-12-12
• Public Version Status: New
• Public Device Record Key: 0cae77aa-44ac-4cb9-9f3e-bddac814cfa3

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
KSS	Supplies, Blood-Bank	Hematology	864.9050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52733	Red cell antibody eluting IVD, kit	A collection of reagents and other associated materials intended to be used for the elution of antibodies bound to antigens present on the surface of red blood cells in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060242472596	GS1

Premarket Submissions

Submission Number	Supplement Number
BK251265	0