FDA Registration
Active
🇺🇸 United States
ARCHITECT Galectin-3 Reagents, Calibrators and Controls (US)
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
- K140436
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 |
|---|---|---|---|---|---|
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2014-12-30 |
| Galectin-3 In Vitro Diagnostic Assay | OSX | Class 2 | Clinical Chemistry | No | 2014-12-30 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2014-12-30 |
Proprietary Names
ARCHITECT Galectin-3 Reagents, Calibrators and Controls (US)
Establishment Types
Manufacture Medical Device