Optimal Hypotonic Solution

Basic Information

• Brand Name: Optimal Hypotonic Solution
• Primary DI: 05060174130106
• Version / Model: GGS - JL005
• Catalog Number: GGS - JL005
• Company Name: GENIAL HELIX LTD
• Labeler DUNS: 219918136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-18
• Public Version: 1
• Public Version Date: 2023-09-26
• Public Version Status: New
• Public Device Record Key: c82c541d-95a2-4a13-8281-7a3018c878b1

Device Description

Optimal Hypotonic Solution is a hypotonic solution which achieves optimum metaphase swelling (spreading) from difficult cells prone to either under spread or overspread where conventional hypotonic solutions achieve inadequate swelling. The solution increases cell volume allowing the chromosomes more room to spread; well spread chromosomes with few crossovers greatly aid analysis. Developed for acute leukaemia bone marrow and tumour cells, also useful with problem blood and other problematic sample types.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KIQ	Kit, Culture, Chromosome	Hematology	864.2260	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64705	Assay development analyte-specific reagent IVD	An antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological specimen for the development of a laboratory developed test (LDT) or commercial in vitro diagnostic medical device (IVD). Commonly referred to as an analyte specific reagent (ASR), it is neither labelled with instructions for use nor diagnostic or performance claims.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060174130106	GS1