FDA Registration
Active
🇺🇸 United States
LIAISON® QuantiFERON® Software
Reg #: 2182595
·
FEI: 2182595
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
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
- PMA Number
- P180047
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 |
|---|---|---|---|---|---|
| Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis | NCD | Class 3 | Unknown | No | 2019-12-01 |
Proprietary Names
LIAISON® QuantiFERON® Software
LIAISON® QuantiFERON®-TB Gold Plus
LIAISON® Control QuantiFERON®-TB Gold Plus
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)