Ortho™ BioClone™ PLUS Anti-N

Basic Information

• Brand Name: Ortho™ BioClone™ PLUS Anti-N
• Primary DI: 05060242472923
• Version / Model: 6141127
• Company Name: ALBA BIOSCIENCE LIMITED
• Labeler DUNS: 516536641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-10
• Public Version: 1
• Public Version Date: 2026-04-20
• Public Version Status: New
• Public Device Record Key: 27bafca7-2d6d-4d60-9383-5bb3c88701e3

Device Description

This Anti-N reagent is for the in vitro detection and identification of the human N blood group antigen by direct agglutination.

Device Characteristics

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

GMDN Terms

Code	Name	Definition	Implantable	Status
52631	Anti-N red blood cell grouping IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used in testing a clinical specimen for N [MNS002] red blood cell antigens from the MNS system, using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05060242472626	GS1		1	In Commercial Distribution
Primary	05060242472923	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius