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Leica Biosystems CytoVision CytoLink Development System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Leica Biosystems CytoVision CytoLink Development System FDA UDI
- Generic Name
- Laboratory instrument/analyser application software IVD FDA UDI
- Device Name
- Leica Biosystems CytoVision CytoLink Development System FDA UDI
- Model / Reference
- 23REV009KFXCL1 FDA UDI
- Description
- Leica Biosystems CytoVision CytoLink Development System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849832005001 FDA UDI
- FDA Product Code
- JOY FDA UDI
- GMDN Term
- Laboratory instrument/analyser application software IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5260 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Leica Biosystems CytoVision CytoLink Development System by Leica Biosystems Richmond, Inc. — Class II — FDA UDI — listed in FDA GUDID
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 II | Pending data |
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Manufacturer
- Manufacturer
- Leica Biosystems Richmond, Inc.
Sources (1)
- FDA UDI 4bf7d50a-a5af-47f6-b318-71aea68a8255 37 fields · synced Jun 1, 2026