FDA Registration
Active
🇬🇧 United Kingdom
IML 2000
Reg #: 3002806944
·
FEI: 3002806944
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED
- Registration Number
- 3002806944
- FEI Number
- 3002806944
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- GLYN RHONWY
- City
- LLANBERIS Wales
- Country
- GB
Regulatory Submissions
- PMA Number
- P060005
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 |
|---|---|---|---|---|---|
| Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions | MTG | Class 3 | Unknown | No | 2008-09-22 |
Proprietary Names
IML 2000
IML 1000
IMMULITE Free PSA
IMMULITE 2000 Free PSA
IMMULITE Free PSA Sample Diluent
Establishment Types
Manufacture Medical Device