AccessGUDID - DEVICE: Optimal Hypotonic Solution (05060174130106)

GUDID

Device Identifier (DI) Information

Brand Name: Optimal Hypotonic Solution
Version or Model: GGS - JL005
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GGS - JL005
Company Name: GENIAL HELIX LTD

Primary DI Number: 05060174130106
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 219918136 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KIQ	Kit, Culture, Chromosome

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c82c541d-95a2-4a13-8281-7a3018c878b1
Public Version Date: September 26, 2023
Public Version Number: 1
DI Record Publish Date: September 18, 2023