FDA Registration
Active
🇺🇸 United States
Emit Cyclosporine Sample Pretreatment Reagent
Reg #: 1643621
·
FEI: 1643621
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Fujirebio Diagnostics, Inc.
- Registration Number
- 1643621
- FEI Number
- 1643621
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 940 Crossroads Blvd
- City
- Seguin
- State
- TX
- ZIP
- 78155
- Country
- US
Regulatory Submissions
- PMA Number
- P920031
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 |
|---|---|---|---|---|---|
| Cyclosporine | MKW | Class 2 | Clinical Chemistry | No | 2020-05-11 |
Proprietary Names
Emit Cyclosporine Sample Pretreatment Reagent
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)