Manufacturer
Alere San Diego
United StatesLegal entities : Alere San Diego, Inc.
Markets : Ireland · United States
Approvals : EU – class A · United States (FDA) – 510(k) : 2 · class I, II · latest in 2023 · see on the FDA website
EU representative : Abbott Rapid Dx International Limited (Ireland)
- 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 |
|---|---|---|---|---|
| Blood collection, capillary tubes | W0501010203 | A IVDR | EUDAMED record Report an error | |
| Capillary blood collection devices - accessories | W0501010280 | A IVDR | EUDAMED record Report an error | |
| IVD general use consumables devices - other accessories | W0580 | A IVDR | EUDAMED record Report an error | |
| Limited panel immunochemistry analysers - other | W0201020299 | A IVDR | EUDAMED record Report an error |
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