LISS

Basic Information

• Brand Name: LISS
• Primary DI: 00858400005121
• Version / Model: 510177
• Company Name: AMERICAN NATIONAL RED CROSS
• Labeler DUNS: 003255213
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-17
• Public Version: 2
• Public Version Date: 2020-07-07
• Public Version Status: Update
• Public Device Record Key: 08cb7cb2-5e06-4e62-b56b-bae25a880838

Device Description

LISS is an additive solution intended for use as a potentiator in antibody detection, identification and compatibility testing. This product is prepared from glycine and albumin.

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
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
Package	10858400005128	GS1		5	In Commercial Distribution
Primary	00858400005121	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 1 – 8 Degrees Celsius