Identity
- Trade Name
- Bone Marrow Growth Supplement FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- Is a media additive that greatly improves cell growth and cytogenetic morphology in bone marrow cultures by exposing these cells to growth factors that are known growth promoters. The additive is also effective with difficult-to-grow solid tumours, lymphomas and products of conception. FDA UDI
- Model / Reference
- GGS - JL002 FDA UDI
- Description
- Is a media additive that greatly improves cell growth and cytogenetic morphology in bone marrow cultures by exposing these cells to growth factors that are known growth promoters. The additive is also effective with difficult-to-grow solid tumours, lymphomas and products of conception. FDA UDI
Identifiers
- Catalog Number
- GGS - JL002 FDA UDI
- Primary DI / UDI-DI
- 05060174130052 FDA UDI
- FDA Product Code
- KIQ FDA UDI
- GMDN Term
- Assay development analyte-specific reagent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.2260 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Assay development analyte-specific reagent IVD
Bone Marrow Growth Supplement by Genial Helix Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Genial Helix Ltd
Sources (1)
- FDA UDI 126a2ba8-dfc1-487e-9adc-580fd6c41d3c 34 fields · synced Jun 1, 2026