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Sign in to claim this brandWhat GENIAL HELIX LTD makes
Genial Helix Ltd produces assay development reagents and analyte-specific in vitro diagnostic (IVD) products, including solutions for cell preparation and growth supplements. Their portfolio includes specialized reagents like hypotonic solutions, lysis solutions, and additives for chromosome resolution, as well as supplements designed for specific tissue or cell types such as bone marrow, lymphoma, and solid tumors.
All listed devices fall under FDA’s Class I regulatory category and are registered in the FDA’s Unique Device Identifier (UDI) database. The company operates within the United States, adhering to applicable IVD and reagent regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 219918136
Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bone Marrow Growth Supplement | GGS - JL002 | FDA UDI | Class I | Active |
| Pre-Hypotonic Solution | GGS - JL007 | FDA UDI | Class I | Active |
| Lymphoma Growth Supplement | GGS - JL011 | FDA UDI | Class I | Active |
| Anticlotting Reagent | GGS - JL001 | FDA UDI | Class I | Active |
| Cytoclear Cytoplasm Remover | GGS - JL004 | FDA UDI | Class I | Active |
| Chromosome Resolution Additive | GGS - JL003 | FDA UDI | Class I | Active |
| Solid Tumor Growth Supplement | GGS - JL010 | FDA UDI | Class I | Active |
| Buffered Hypotonic Solution | GGS - JL006 | FDA UDI | Class I | Active |
| Skin Growth Supplement | GGS - JL012 | FDA UDI | Class I | Active |
| Optimal Hypotonic Solution | GGS - JL005 | FDA UDI | Class I | Active |
| Product of Conception Growth Supplement | GGS - JL013 | FDA UDI | Class I | Active |
| Erythrocyte Lysis Solution | GGS - JL009 | FDA UDI | Class I | Active |
| Lymphocyte Growth Supplement | GGS - JL002L | FDA UDI | Class I | Active |
| Metaphase Arresting Solution | GGS - JL008 | FDA UDI | Class I | Active |
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