FDA Registration
Active
🇺🇸 United States
ADVIA Centaur
Reg #: 1219913
·
FEI: 1219913
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Siemens Healthcare Diagnostics Inc.
- Registration Number
- 1219913
- FEI Number
- 1219913
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 333 Coney Street
- City
- E Walpole
- State
- MA
- ZIP
- 02032
- Country
- US
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 |
|---|---|---|---|---|---|
| Chemiluminescent Immunoassay System | PKM | Class N | Unknown | No | 2015-04-17 |
Proprietary Names
ADVIA Centaur
Atellica IM PIIINP (PIIINP)
Atellica IM TIMP-1 (TIMP-1)
Atellica IM Enhanced Liver Fibrosis Calibrator (ELF CAL)
Atellica IM HA (HA)
ADVIA Centaur Enhanced Liver Fibrosis Calibrator (ELF CAL)
Establishment Types
Manufacture Device in the United States for Export Only