FDA Registration
Active
🇨🇭 Switzerland
Analyzer for Clinical Use, Various
Reg #: 3003795116
·
FEI: 3003795116
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ROCHE DIAGNOSTICS INTERNATIONAL LTD.
- Registration Number
- 3003795116
- FEI Number
- 3003795116
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- FORRENSTRASSE 2
- City
- ROTKREUZ Zug
- Country
- CH
Owner / Operator
- Firm Name
- Roche Diagnostics Operations Inc.
- Operator Number
- 9039767
- Address
- 9115 Hague Road
- City
- Indianapolis
- State
- IN
- Postal Code
- 46250
- Country
- US
US Agent
- Business Name
- Roche Diagnostics Operations Inc
- Contact Name
- Brian Frazier
- Address
- 9115 Hague Rd
- City
- Indianapolis
- State
- IN
- ZIP
- 46256
- Country
- US
- [email protected]
- Phone
- 317 5214603
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Chemistry, Micro, For Clinical Use | JJF | Class 1 | Clinical Chemistry | No | 2008-06-12 |
Proprietary Names
Analyzer for Clinical Use, Various
Lightcycler Products
Establishment Types
Manufacture Medical Device