FDA Registration
Active
🇪🇸 Spain
QUANTIA Proteins Control
Reg #: 9610746
·
FEI: 3002806557
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- BIOKIT S.A.
- Registration Number
- 9610746
- FEI Number
- 3002806557
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- AV. CAN MONTCAU 7
- City
- LLISSA D AMUNT Barcelona
- Country
- ES
Regulatory Submissions
- 510(k) Number
- K050613
Owner / Operator
- Firm Name
- BIOKIT S.A.
- Operator Number
- 8030752
- Address
- AV CAN MONTCAU, 7, --
- City
- LLISSA D'AMUNT, BARCELONA
- State
- ES-B
- Postal Code
- 08186
- Country
- ES
- Correspondent
- ANGELS - ROMA
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Beta-2-Microglobulin Immunological | JZG | Class 2 | Immunology | No | 1996-03-20 |
| Controls For Blood-Gases, (Assayed And Unassayed) | JJS | Class 1 | Clinical Chemistry | No | 1996-03-20 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 1996-03-20 |
Proprietary Names
QUANTIA Proteins Control
QUANTIA B2-Microglobulin Calibrator
QUANTIA B2-Microglobulin
Establishment Types
Manufacture Medical Device