Identity
- Trade Name
- Optimal Hypotonic Solution FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- Optimal Hypotonic Solution is a hypotonic solution which achieves optimum metaphase swelling (spreading) from difficult cells prone to either under spread or overspread where conventional hypotonic solutions achieve inadequate swelling. The solution increases cell volume allowing the chromosomes more room to spread; well spread chromosomes with few crossovers greatly aid analysis. Developed for acute leukaemia bone marrow and tumour cells, also useful with problem blood and other problematic sample types. FDA UDI
- Model / Reference
- GGS - JL005 FDA UDI
- Description
- Optimal Hypotonic Solution is a hypotonic solution which achieves optimum metaphase swelling (spreading) from difficult cells prone to either under spread or overspread where conventional hypotonic solutions achieve inadequate swelling. The solution increases cell volume allowing the chromosomes more room to spread; well spread chromosomes with few crossovers greatly aid analysis. Developed for acute leukaemia bone marrow and tumour cells, also useful with problem blood and other problematic sample types. FDA UDI
Identifiers
- Catalog Number
- GGS - JL005 FDA UDI
- Primary DI / UDI-DI
- 05060174130106 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
Optimal Hypotonic Solution by Genial Helix Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Assay development analyte-specific reagent IVD.
- PE/Dazzle™ 594 anti-human CD38 — BIOLEGEND, INC. · Class I
- Immunalysis — Immunalysis Corporation · Class I
- Immunalysis — Immunalysis Corporation · Class I
- Beckmancoulter — Immunotech Corp. · Class I
- Beckmancoulter — Immunotech Corp. · Class I
- MetaSystems Probes — MetaSystems Probes GmbH · Class I
- Helicobacter Pylori (EP279) — BIO SB, INC. · Class I
- CytoCell — Cytocell, Ltd. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Genial Helix Ltd
Sources (1)
- FDA UDI c82c541d-95a2-4a13-8281-7a3018c878b1 34 fields · synced May 31, 2026