FDA Registration
Active
🇺🇸 United States
Dimension Vista UCFP Flex
Reg #: 2432235
·
FEI: 2432235
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Siemens Healthcare Diagnostics Inc.
- Registration Number
- 2432235
- FEI Number
- 2432235
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 511 Benedict Ave
- City
- Tarrytown
- State
- NY
- ZIP
- 10591
- 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 |
|---|---|---|---|---|---|
| Biuret (Colorimetric), Total Protein | CEK | Class 2 | Clinical Chemistry | No | 2002-05-07 |
Proprietary Names
Dimension Vista UCFP Flex
Dimension Vista TP Flex
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP)
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP)
Atellica CH Total Protein II (TP)
ADVIA Chemistry TP_c
Atellica CH Total Protein_2 (TP_2)
ADVIA Chemistry TP
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility