FDA Registration
Active
🇺🇸 United States
HPV 16 mRNA Probe
Reg #: 2028492
·
FEI: 1000125183
·
Expires 2025
Products
1
Proprietary Names
19
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 |
|---|---|---|---|---|---|
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 2000-02-04 |
Proprietary Names
HPV 16 mRNA Probe
U6 DNP Probe
Lambda DNP Probe (704-733)
Kappa DNP Probe (538-567)
Chromosome 7 DIG Probe
Chromosome 12 DIG Probe
HPV 6 mRNA Probe
Kappa DNP Probe (495-524)
Kappa DNP Probe (637-666)
Kappa DNP Probe (597-626)
HPV 11 mRNA Probe
HPV 33 mRNA Probe
Lambda DNP Probe (768-797)
Lambda DNP Probe (664-693)
HPV 18 mRNA Probe
EGFR DNP Probe
Lambda DNP Probe (826-855)
EBER 1 DNP Probe
EBER1 DIG Probe
Establishment Types
Manufacture Medical Device