Identity
- Trade Name
- Metaphase Arresting Solution FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- Metaphase Arresting Solution is a mixture of colchicine/vinblastine sulphate dissolved in PBS. Both of these compounds inhibit the formation of mitotic spindles and are used to increase the percentage of metaphase cells for chromosome studies. Vinblastine sulphate has been found to be more effective against bone marrows, difficult tumours and problematic tissues with low mitotic indexes, and where colchicine/colcemid appears to be ineffective. FDA UDI
- Model / Reference
- GGS - JL008 FDA UDI
- Description
- Metaphase Arresting Solution is a mixture of colchicine/vinblastine sulphate dissolved in PBS. Both of these compounds inhibit the formation of mitotic spindles and are used to increase the percentage of metaphase cells for chromosome studies. Vinblastine sulphate has been found to be more effective against bone marrows, difficult tumours and problematic tissues with low mitotic indexes, and where colchicine/colcemid appears to be ineffective. FDA UDI
Identifiers
- Catalog Number
- GGS - JL008 FDA UDI
- Primary DI / UDI-DI
- 05060174130076 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
Metaphase Arresting Solution 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 eb3d19da-885c-4b7e-a04e-bfb561757d35 34 fields · synced May 30, 2026