Identity
- Trade Name
- Thermo Fisher FDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- HEATED FDA UDI
- Model / Reference
- Gemini AS FDA UDI
- Description
- HEATED FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051663002950 FDA UDI
- FDA Product Code
- KPA FDA UDI
- GMDN Term
- Microscope slide stainer IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3800 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Microscope slide stainer IVD
Thermo Fisher by Shandon Diagnostics Limited — 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
- Shandon Diagnostics Limited
Sources (1)
- FDA UDI 6909213c-95a3-4e95-9189-80e1c1f03aca 33 fields · synced Jun 8, 2026