Identity
- Trade Name
- For DI Remote Review Software version 5.0.x 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 DI-60 with the ability to reclassify cells and sign off slides from another location. FDA UDI
- Model / Reference
- BC188562 FDA UDI
- Description
- The CellaVision remote review software enable remote users to access data collected, stored and processed by DI-60 with the ability to reclassify cells and sign off slides from another location. FDA UDI
Identifiers
- Catalog Number
- BC188562 FDA UDI
- Primary DI / UDI-DI
- 07350040974728 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
- 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
Category: Laboratory instrument/analyser application software IVD
For DI Remote Review Software version 5.0.x by Cellavision AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K102778 also covers:
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 8b111f0a-5a07-4dcc-bc38-aa852e6f85bd 36 fields · synced Jun 1, 2026