ALBAhance LISS Additive Reagent

Basic Information

• Brand Name: ALBAhance LISS Additive Reagent
• Primary DI: 05060242471544
• Version / Model: Z333U
• Company Name: ALBA BIOSCIENCE LIMITED
• Labeler DUNS: 516536641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-11-14
• Public Version: 6
• Public Version Date: 2022-03-31
• Public Version Status: Update
• Public Device Record Key: 40b4435b-df5e-42a4-808c-68b2f48c80ef

Device Description

ALBAhance LISS Additive Reagent.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• 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
KSK	Solution, Stabilized Enzyme	Hematology	864.9400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52718	Low ionic-strength salt solution (LISS) immunohaematology reagent IVD	A substance or reactant known as low ionic-strength salt solution (LISS), or low ionic strength saline, intended to be used in immunohaematological testing of a clinical specimen to enhance or potentiate red cell agglutination reactions. It is a solution typically consisting of a sodium salt, glycine and low-salt albumin.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060242471544	GS1
Package	05060242471117	GS1	Carton	10	In Commercial Distribution

Customer Contacts

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