Manufacturer
Biohit
FinlandLegal entities : Biohit Oyj
Markets : Finland · United States
Approvals : EU – class A · United States (FDA) – 510(k) : 1 · class I, II · latest in 2004 · see on the FDA website
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a category to see competitors, a model to open its EUDAMED record.
| Category | EMDN code | Registered models | Class | Contact |
|---|---|---|---|---|
| Faeces collection devices | W05019001 | A IVDR | EUDAMED record Report an error | |
| H. pylori - RT & POC | W0105090102 |
|
– 98/79 | EUDAMED record Report an error |
| Various rapid test chemistry / immunochemistry instruments - other | W0201069099 |
|
A IVDR, 98/79 | EUDAMED record Report an error |
| Controls infectious immunology - RT & POC | W0105094001 | – 98/79 | EUDAMED record Report an error | |
| H. pylori antibody assays | W0105010402 | – 98/79 | EUDAMED record Report an error | |
| Limited panel immunochemistry analysers - IVD medical device software | W0201020292 |
|
– 98/79 | EUDAMED record Report an error |
| Various rapid test chemistry / immunochemistry instruments - hardware accessories | W0201069080 |
|
A IVDR | EUDAMED record Report an error |
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