Identity
- Trade Name
- Buffered Hypotonic Solution FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- Buffered Hypotonic Solution is a hypotonic solution developed for bone marrow specimens. It has been found to achieve good metaphase swelling (spreading) from a wide range of sample types and significantly increases the number of useful metaphases in leukaemic bone marrow cultures. FDA UDI
- Model / Reference
- GGS - JL006 FDA UDI
- Description
- Buffered Hypotonic Solution is a hypotonic solution developed for bone marrow specimens. It has been found to achieve good metaphase swelling (spreading) from a wide range of sample types and significantly increases the number of useful metaphases in leukaemic bone marrow cultures. FDA UDI
Identifiers
- Catalog Number
- GGS - JL006 FDA UDI
- Primary DI / UDI-DI
- 05060174130090 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
Buffered Hypotonic 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 fee3e891-6d4d-4428-a261-2d3864ffbccc 34 fields · synced Jun 6, 2026