FDA Registration
Active
🇸🇪 Sweden
Mesothelin Control
Reg #: 3027273565
·
FEI: 3027273565
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Fujirebio Diagnostics AB
- Registration Number
- 3027273565
- FEI Number
- 3027273565
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Gemenskapens gata 7
- City
- Molndal Vastra Gotaland
- Country
- SE
Owner / Operator
- Firm Name
- Fujirebio Diagnostics, Inc.
- Operator Number
- 10022860
- Address
- 201 Great Valley Parkway
- City
- Malvern
- State
- PA
- Postal Code
- 19355
- Country
- US
- Correspondent
- Greg Dickson
US Agent
- Business Name
- FUJIREBIO DIAGNOSTICS, INC.
- Contact Name
- Greg Dickson
- Address
- 201 Great Valley Parkway
- City
- Malvern
- State
- PA
- ZIP
- 19355
- Country
- US
- [email protected]
- Phone
- 610 2403888
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2019-03-05 |
Proprietary Names
Mesothelin Control
AMH Control
Lung Marker Control
Establishment Types
Manufacture Medical Device