FDA Registration
Active
🇧🇪 Belgium
25 OH vit D Total ELISA
Reg #: 3009335633
·
FEI: 3009335633
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DiaSource ImmunoAssays, SA
- Registration Number
- 3009335633
- FEI Number
- 3009335633
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Rue du Bosquet 2
- City
- Louvain-La-Neuve Brabant Wallon
- Country
- BE
Regulatory Submissions
- 510(k) Number
- K123364
Owner / Operator
- Firm Name
- DIAsource ImmunoAssays, SA
- Operator Number
- 10037912
- Address
- Rue du Bosquet, 2
- City
- Louvain-La-Neuve
- State
- BE-NOTA
- Postal Code
- 1348
- Country
- BE
US Agent
- Business Name
- Gold Standard Diagnostics
- Contact Name
- Tony Sanford
- Address
- 2851 Spafford St
- City
- Davis
- State
- CA
- ZIP
- 95618
- Country
- US
- [email protected]
- Phone
- 530 7598000
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Vitamin D | MRG | Class 2 | Clinical Chemistry | No | 2013-07-22 |
Proprietary Names
25 OH vit D Total ELISA
Establishment Types
Manufacture Medical Device