FDA Registration
Active
🇨🇭 Switzerland
cobas pure integrated solutions
Reg #: 3003795116
·
FEI: 3003795116
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
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
Regulatory Submissions
- 510(k) Number
- K220134
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 |
|---|---|---|---|---|---|
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2022-09-19 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2022-09-19 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2022-09-19 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2022-09-19 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2022-09-19 |
Proprietary Names
cobas pure integrated solutions
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility