FDA Registration
Active
🇯🇵 Japan
ST AIA-PACK D-Dimer Calibrator Set
Reg #: 9612316
·
FEI: 3002808328
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TOSOH AIA, INC.
- Registration Number
- 9612316
- FEI Number
- 3002808328
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2, IWASEKOSHI-MACHI
- City
- TOYAMA
- Country
- JP
Owner / Operator
- Firm Name
- TOSOH BIOSCIENCE
- Operator Number
- 8031673
- Address
- 3600 Gantz Road
- City
- Grove City
- State
- OH
- Postal Code
- 43123
- Country
- US
- Correspondent
- Joshua D Levin
US Agent
- Business Name
- Tosoh Bioscience Inc.
- Contact Name
- Dave Wurtz
- Address
- 3600 Gantz Road
- City
- Grove City
- State
- OH
- ZIP
- 43123
- Country
- US
- [email protected]
- Phone
- 415 6354762
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fibrin Split Products | GHH | Class 2 | Hematology | No | 2017-06-12 |
Proprietary Names
ST AIA-PACK D-Dimer Calibrator Set
ST AIA-PACK D-Dimer Control Set
ST AIA-PACK D-Dimer
ST AIA-PACK D-Dimer Sample Diluting Solution
CL AIA-PACK D-Dimer
CL AIA-PACK D-Dimer Adjuster Set
Establishment Types
Manufacture Medical Device