FDA Registration
Inactive
🇸🇪 Sweden
EliA Scl-70S Immunoassay
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PHADIA AB
- Status
- Inactive
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Almungevagen 35
- City
- Uppsala
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K140493
Owner / Operator
- Firm Name
- PHADIA AB
- Operator Number
- 9004441
- Address
- Rapsgatan 7P, P.O. Box 6460
- City
- UPPSALA
- State
- SE-C
- Postal Code
- 75137
- Country
- SE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | LJM | Class 2 | Immunology | No | 2014-11-04 |
Proprietary Names
EliA Scl-70S Immunoassay
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)