| Primary Device ID | 05060174130144 |
| NIH Device Record Key | e76513f8-229b-45c2-82c6-8922a46f44fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lymphoma Growth Supplement |
| Version Model Number | GGS - JL011 |
| Catalog Number | GGS - JL011 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 05060174130144 [Primary] |
| KIQ | Kit, Culture, Chromosome |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-26 |
| Device Publish Date | 2023-09-18 |
| 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 | 2023-09-26 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 |