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CellaVision® Remote Review Software version 5.0.x, Non-expiring license
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- CellaVision® Remote Review Software version 5.0.x, Non-expiring license FDA UDI
- Generic Name
- Laboratory instrument/analyser application software IVD FDA UDI
- Device Name
- The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location. FDA UDI
- Model / Reference
- CRRS-005099 FDA UDI
- Description
- The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location. FDA UDI
Identifiers
- Catalog Number
- CRRS-005099 FDA UDI
- Primary DI / UDI-DI
- 07350040973714 FDA UDI
- 510(k) Number
- K102778 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
CellaVision® Remote Review Software version 5.0.x, Non-expiring license by Cellavision AB — Class II — FDA UDI — listed in FDA GUDID
Cleared under the same submission
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
- Cellavision AB
Sources (1)
- FDA UDI 2e3747ad-9d57-493c-9e83-c7f4bd55ad53 37 fields · synced Jun 8, 2026