Biokit S.A.
ES-MF-000002406 · Spain · LLIÇÀ D´AMUNT (BARCELONA)
Biokit S.A. is registered in the European database on medical devices as a manufacturer, with 83 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: 0009802044, 0020300900, 3000-2269, 3000-2270.
Devices declared under this manufacturer
- Alinity c ASO-RF Control I Kit
- BIO-FLASH Screw Caps for Sample Cups
- BIO-FLASH System Cleaning Solution
- BIO-FLASH Triggers
- CRP plus Calibrator
- IgA
- Lp(a)
- Lp(a) Controls
- QUANTIA ASO-RF CONTROL II
- Quantia Ferritin
- Quantia Ferritin Standard
- Quantia β2-Microglobulin
Showing 12 of 83 declared devices.
Catalogue references include 04S0910, 3000-2252, 3000-7010, 3000-8204, 6K39-02, 6K41-02.
European nomenclature codes declared: W0102010405, W0201020185, W0102152003, W0102019099, W0102080102, W0201020180.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BIOKIT S.A. (ES) · FDA 9610746 |
| Devices in EUDAMED | 83 |
| Country of registration | Spain |
Device-level evidence
| Devices with a numeric GTIN | 74 |
|---|---|
| Found in the U.S. device database | 8 |
| Share | 10.8 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BIOKIT S.A. |
What it holds in Canada
| Licences on record | 28 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 28 |
| First licensed | 2001-06-29 |
Licence types: Test Kit (26), Single Device (1), System (1).
Licensed under: QUANTIA ASO, QUANTIA IGE, QUANTIA RF, QUANTIA A-1-AGP, QUANTIA A1-ANTITRYPSIN, QUANTIA B2-MICROGLOBULIN.
North American profile: Both markets. Biokit S.A. is registered in both the United States and Canada.