Erythrocyte Lysis Solution GGS - JL009

GUDID 05060174130038

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.

GENIAL HELIX LTD

Assay development analyte-specific reagent IVD

• Primary Device ID: 05060174130038
• NIH Device Record Key: 7ab0afbd-bd79-4125-a932-27c972245b55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Erythrocyte Lysis Solution
• Version Model Number: GGS - JL009
• Catalog Number: GGS - JL009
• Company DUNS: 219918136
• Company Name: GENIAL HELIX LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060174130038 [Primary]

FDA Product Code

• KIQ: Kit, Culture, Chromosome

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-26
• Device Publish Date: 2023-09-18

Devices Manufactured by GENIAL HELIX LTD

• 05060174130021 - Anticlotting Reagent: 2023-09-26 AntiClotting Reagent Is an additive that quickly breaks down the proteins that comprise blood clots within cytogenetic samples
• 05060174130038 - Erythrocyte Lysis Solution: 2023-09-26Erythrocyte 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.
• 05060174130038 - Erythrocyte Lysis Solution: 2023-09-26 Erythrocyte Lysis Solution is a simple pretreatment for heavily blood-stained amniotic fluid and bone marrow samples which quick
• 05060174130045 - Lymphocyte Growth Supplement: 2023-09-26 Lymphocyte Growth Supplement is a media additive that greatly improves cell growth and cytogenetic morphology in blood cultures
• 05060174130052 - Bone Marrow Growth Supplement: 2023-09-26 Is a media additive that greatly improves cell growth and cytogenetic morphology in bone marrow cultures by exposing these cells
• 05060174130069 - Chromosome Resolution Additive: 2023-09-26 Chromosome Resolution Additive is a formulation that consistently prevents chromosome contraction and encourages chromosome elon
• 05060174130076 - Metaphase Arresting Solution: 2023-09-26 Metaphase Arresting Solution is a mixture of colchicine/vinblastine sulphate dissolved in PBS. Both of these compounds inhibit
• 05060174130083 - Pre-Hypotonic Solution: 2023-09-26 Pre-Hypotonic Solution is to be used before the hypotonic stage of a blood or bone marrow harvest; pre-hypotonic solution makes
• 05060174130090 - Buffered Hypotonic Solution: 2023-09-26 Buffered Hypotonic Solution is a hypotonic solution developed for bone marrow specimens. It has been found to achieve good metap