FDA Registration
Active
🇺🇸 United States
Atellica VTLi hs-cTnI Reagent Cartridge
Reg #: 3009448641
·
FEI: 3009448641
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Siemens Healthcare Diagnostics, Inc.
- Registration Number
- 3009448641
- FEI Number
- 3009448641
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 430 S Beiger St
- City
- Mishawaka
- State
- IN
- ZIP
- 46544
- 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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2021-07-20 |
Proprietary Names
Atellica VTLi hs-cTnI Reagent Cartridge
Establishment Types
Manufacture Device in the United States for Export Only