FDA Registration
Active
🇺🇸 United States
BenchMark XT system
Reg #: 2028492
·
FEI: 1000125183
·
Expires 2025
Products
1
Proprietary Names
14
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- VENTANA MEDICAL SYSTEMS, INC.
- Registration Number
- 2028492
- FEI Number
- 1000125183
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1910 EAST INNOVATION PARK DR.
- City
- Tucson
- State
- AZ
- ZIP
- 85755
- Country
- US
Owner / Operator
- Firm Name
- Roche Diagnostics Operations Inc.
- Operator Number
- 9039767
- Address
- 9115 Hague Road
- City
- Indianapolis
- State
- IN
- Postal Code
- 46250
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Slide Stainer, Automated | KPA | Class 1 | Pathology | No | 2016-11-10 |
Proprietary Names
BenchMark XT system
BenchMark GX system
VENTANA HE 600 system
BenchMark ULTRA system
VENTANA HE 600 v1.9.2 Installer
BenchMark Special Stains System
Software Supplement S Trichrome
VSS 12.5.2 Software Update Installer
PC ASSEMBLY, VENTANA HE 600
HE 600 1.9.4 Software Update Installer
HE 600 1.9.5 Software Update Installer
BenchMark ULTRA PLUS Instrument
VENTANA HE 600 V1.10 Installer
BENCHMARK ULTRA PLUS INSTRUMENT
Establishment Types
Manufacture Medical Device