FDA Registration
Active
🇬🇧 United Kingdom
A482 (Native Ole e 1)
Reg #: 3002806944
·
FEI: 3002806944
·
Expires 2025
Products
1
Proprietary Names
6
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
- 510(k) Number
- K112523
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 |
|---|---|---|---|---|---|
| System, Test, Radioallergosorbent (Rast) Immunological | DHB | Class 2 | Immunology | No | 2012-01-17 |
Proprietary Names
A482 (Native Ole e 1)
A753 (Native Art v 1)
Specific Allergens:
E221 (Dog Serum Albumin, Can f 3)
A89 (Native Bet v 1)
E220 (Cat Serum Albumin, Fel d 2)
Establishment Types
Manufacture Medical Device