Identity
- Trade Name
- CytoVision V7.6 configuration FDA UDI
- Generic Name
- Laboratory instrument/analyser application software IVD FDA UDI
- Device Name
- CytoVision V7.6 configuration FDA UDI
- Model / Reference
- 23SWR00076CV FDA UDI
- Description
- CytoVision V7.6 configuration FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849832013419 FDA UDI
- 510(k) Number
- K042542 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
CytoVision V7.6 configuration by Leica Biosystems Richmond, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K042542 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
- Leica Biosystems Richmond, Inc.
Sources (1)
- FDA UDI 63056e36-6b61-4dcf-abb2-536e4ab4a2ee 38 fields · synced Jun 6, 2026