FDA Registration
Active
🇺🇸 United States
Syva RapidTest d.a.u. OPI
Reg #: 2517506
·
FEI: 2517506
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Registration Number
- 2517506
- FEI Number
- 2517506
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 500 GBC DR, PO Box 6101
- City
- NEWARK
- State
- DE
- ZIP
- 19714
- Country
- US
Regulatory Submissions
- 510(k) Number
- K945608
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 |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2017-09-05 |
Proprietary Names
Syva RapidTest d.a.u. OPI
Establishment Types
Manufacture Medical Device