IH-LISS Solution

Basic Information

• Brand Name: IH-LISS Solution
• Primary DI: 07611969952182
• Version / Model: 813520100
• Company Name: Bio-Rad Medical Diagnostics GmbH
• Labeler DUNS: 312576506
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-05
• Public Version: 3
• Public Version Date: 2020-07-07
• Public Version Status: Update
• Public Device Record Key: 01dde623-b952-4bb2-a810-d6f466c9f192

Device Description

LISS Solution; 2 x 100 mL bottle for Use with the IH-System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: 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
KSG	Media, Potentiating For In Vitro Diagnostic Use	Hematology	864.9600	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	07611969952182	GS1

Customer Contacts

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