Chromosome Resolution Additive GGS - JL003

GUDID 05060174130069

Chromosome Resolution Additive is a formulation that consistently prevents chromosome contraction and encourages chromosome elongation by loosening the chemical bonding within the supercoiled structure. It has been designed for use with tissues resistant to existing prophase techniques such as bone marrows and solid tumors.

GENIAL HELIX LTD

Assay development analyte-specific reagent IVD

• Primary Device ID: 05060174130069
• NIH Device Record Key: 0f2692c9-30c1-4eba-a100-69de7e0ddcdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chromosome Resolution Additive
• Version Model Number: GGS - JL003
• Catalog Number: GGS - JL003
• 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	05060174130069 [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

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• 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: 2023-09-26Chromosome Resolution Additive is a formulation that consistently prevents chromosome contraction and encourages chromosome elongation by loosening the chemical bonding within the supercoiled structure. It has been designed for use with tissues resistant to existing prophase techniques such as bone marrows and solid tumors.
• 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