FDA Registration
Active
🇺🇸 United States
Alinity i Tacrolimus Test Kit (Reagent, Calibrator, Controls)
Reg #: 2521625
·
FEI: 2521625
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Fujirebio Diagnostics, Inc.
- Registration Number
- 2521625
- FEI Number
- 2521625
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 201 Great Valley Parkway
- City
- Malvern
- State
- PA
- ZIP
- 19355
- Country
- US
Owner / Operator
- Firm Name
- Fujirebio Diagnostics, Inc.
- Operator Number
- 10022860
- Address
- 201 Great Valley Parkway
- City
- Malvern
- State
- PA
- Postal Code
- 19355
- Country
- US
- Correspondent
- Greg Dickson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Tracrolimus | MLM | Class 2 | Clinical Chemistry | No | 2019-05-17 |
Proprietary Names
Alinity i Tacrolimus Test Kit (Reagent, Calibrator, Controls)
ARCHITECT Tacrolimus Test Kit (Reagent, Calibrator, Controls)
Establishment Types
Manufacture Device in the United States for Export Only