FDA Registration
Active
🇺🇸 United States
ARCHITECT BNP Reagents, Calibrators and Controls
Reg #: 2521625
·
FEI: 2521625
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
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
Regulatory Submissions
- 510(k) Number
- K060964
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 |
|---|---|---|---|---|---|
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2007-10-17 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2007-10-17 |
| Test, Natriuretic Peptide | NBC | Class 2 | Clinical Chemistry | No | 2007-10-17 |
Proprietary Names
ARCHITECT BNP Reagents, Calibrators and Controls
Establishment Types
Manufacture Medical Device