FDA Registration
Active
🇩🇪 Germany
IL 6 CS Elecsys
Reg #: 9610126
·
FEI: 3002806559
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ROCHE DIAGNOSTICS GMBH
- Registration Number
- 9610126
- FEI Number
- 3002806559
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- SANDHOFER STRASSE 116
- City
- MANNHEIM Baden-Wurttemberg
- Country
- DE
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 |
|---|---|---|---|---|---|
| Interleukin 6 | QLC | Class N | Unknown | No | 2020-06-03 |
Proprietary Names
IL 6 CS Elecsys
IL-6 CalSet
IL 6 Elecsys E2G 100
IL 6 Elecsys cobas e 100
Elecsys IL-6
Establishment Types
Manufacture Medical Device