FDA Registration
Active
🇺🇸 United States
Linearity FD D-Dimer PATHFAST Immunoanalyzer
Reg #: 3011325031
·
FEI: 3011325031
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- AALTO SCIENTIFIC LTD.
- Registration Number
- 3011325031
- FEI Number
- 3011325031
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 230 Technology Pkwy
- City
- Eatonton
- State
- GA
- ZIP
- 31024
- Country
- US
Owner / Operator
- Firm Name
- AALTO SCIENTIFIC LTD.
- Operator Number
- 9000089
- Address
- 230 Technology Parkway, --
- City
- Eatonton
- State
- GA
- Postal Code
- 31024
- Country
- US
- Correspondent
- Robert - Burda
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plasma, Coagulation Control | GGN | Class 2 | Hematology | No | 2019-08-26 |
Proprietary Names
Linearity FD D-Dimer PATHFAST Immunoanalyzer
Linearity FD D-Dimer bioMerieux VIDAS and miniVIDAS
Control FD D-Dimer
Linearity FD D-Dimer
Linearity FD D-Dimer for Stago Systems
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device