AccessGUDID - DEVICE: Erythrocyte Lysis Solution (05060174130038)

GUDID

Device Identifier (DI) Information

Brand Name: Erythrocyte Lysis Solution
Version or Model: GGS - JL009
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GGS - JL009
Company Name: GENIAL HELIX LTD

Primary DI Number: 05060174130038
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 219918136 *Terms of Use

Device Description: Erythrocyte Lysis Solution is a simple pretreatment for heavily blood-stained amniotic fluid and bone marrow samples which quickly removes heavy red blood cell (erythrocyte) contamination. Unlike many similar products used in molecular biology that lyse red blood cells, this product is extremely gentle in its action and is specially suited for cytogenetic cell culture work. It is well documented that high concentrations of red blood cells inhibit growth of cells from amniotic fluid by restricting colony size.

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: 7ab0afbd-bd79-4125-a932-27c972245b55
Public Version Date: September 26, 2023
Public Version Number: 1
DI Record Publish Date: September 18, 2023