FDA Registration
Active
🇩🇪 Germany
Vista PROT1 CON L
Reg #: 9610806
·
FEI: 3001644026
·
Expires 2025
Products
3
Proprietary Names
4
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Siemens Healthcare Diagnostics Products GmbH
- Registration Number
- 9610806
- FEI Number
- 3001644026
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 76 EMIL-VON-BEHRING STRASSE
- City
- MARBURG Hesse
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K083463
Owner / Operator
- Firm Name
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Operator Number
- 9096044
- Address
- Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
- City
- Tarrytown
- State
- NY
- Postal Code
- 10591
- Country
- US
- Correspondent
- Mary Seeger
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Beta-2-Microglobulin Immunological | JZG | Class 2 | Immunology | No | 2009-04-02 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2009-04-02 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2009-04-02 |
Proprietary Names
Vista PROT1 CON L
Vista B2MIC Flex
Vista PROT1 CON M
Vista PROT1 Cal
Establishment Types
Manufacture Medical Device