FDA Registration
Active
🇺🇸 United States
PMS2 (A16-4) MM PAB
Reg #: 2028492
·
FEI: 1000125183
·
Expires 2025
Products
1
Proprietary Names
9
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 |
|---|---|---|---|---|---|
| Lynch Syndrome Test System | PZJ | Class 2 | Immunology | No | 2017-11-29 |
Proprietary Names
PMS2 (A16-4) MM PAB
MLH1 (M1) MM PAB
MSH6 (SP93) RM PAB
BRAF V600E (VE1) MM PAB
MSH2 (G219-1129) MM PAB
VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody
VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody
VENTANA anti-MSH6 (SP93) Rabbit Monoclonal Primary Antbody
VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody
Establishment Types
Manufacture Device in the United States for Export Only