FDA Registration
Active
🇺🇸 United States
DIASORIN INC.
Reg #: 2182595
·
FEI: 2182595
·
Expires 2025
Products
3
Proprietary Names
0
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- DIASORIN INC.
- Registration Number
- 2182595
- FEI Number
- 2182595
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1951 Northwestern Ave
- City
- Stillwater
- State
- MN
- ZIP
- 55082
- Country
- US
Regulatory Submissions
- 510(k) Number
- K042643
Owner / Operator
- Firm Name
- DiaSorin Inc.
- Operator Number
- 9051149
- Address
- 1951 Northwestern Ave
- City
- Stillwater
- State
- MN
- Postal Code
- 55082
- Country
- US
- Correspondent
- Mari Meyer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2013-01-04 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2013-01-04 |
| Albumin, Antigen, Antiserum, Control | DCF | Class 2 | Immunology | No | 2013-01-04 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)