Identity
- Trade Name
- Cytoclear Cytoplasm Remover FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- Cytoclear Cytoplasm Remover is a formulation which quickly dissolves and removes persistent cytoplasm during the methanol:acetic acid fixation stage of chromosome harvesting. In particular it dissolves the lipid and glycoprotein structure of which the cytoplasm is mainly composed FDA UDI
- Model / Reference
- GGS - JL004 FDA UDI
- Description
- Cytoclear Cytoplasm Remover is a formulation which quickly dissolves and removes persistent cytoplasm during the methanol:acetic acid fixation stage of chromosome harvesting. In particular it dissolves the lipid and glycoprotein structure of which the cytoplasm is mainly composed FDA UDI
Identifiers
- Catalog Number
- GGS - JL004 FDA UDI
- Primary DI / UDI-DI
- 05060174130113 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
Cytoclear Cytoplasm Remover 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 7b1241e2-5eaf-43c4-bf00-18776e018716 34 fields · synced May 30, 2026