Identity
- Trade Name
- VIRTUOSO System for IHC FDA UDI
- Generic Name
- Histology/cytology/microbiology image-analysis interpretive software IVD FDA UDI
- Model / Reference
- v5 FDA UDI
Identifiers
- Catalog Number
- 06324444001 FDA UDI
- Primary DI / UDI-DI
- 04015630985043 FDA UDI
- FDA Product Code
- NQN FDA UDI
- GMDN Term
- Histology/cytology/microbiology image-analysis interpretive software IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.1860 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
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: Histology/cytology/microbiology image-analysis interpretive software IVD
VIRTUOSO System for IHC by Ventana Medical Systems — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Ventana Medical Systems
Sources (1)
- FDA UDI 77a41492-83c0-4262-80fa-6f8dfb4e6cfd 33 fields · synced May 31, 2026