Manufacturer
Remel
United StatesLegal entities : Remel, Inc.
Markets : Netherlands · United States
Approvals : EU – class A, B · United States (FDA) – 510(k) : 164 · class I, II · latest in 2017 · see on the FDA website
EU representative : Thermo Fisher Diagnostics B.V. (Netherlands)
- 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 |
|---|---|---|---|---|
| Influenza & para influenza | W0105040604 | – 98/79 | EUDAMED record Report an error | |
| C.difficile toxin a/b detection | W0105011802 | – 98/79 | EUDAMED record Report an error | |
| Candida albicans | W0105060302 | B IVDR | EUDAMED record Report an error | |
| Cryptococcus | W0105060303 | – 98/79 | EUDAMED record Report an error | |
| IVD general use consumables devices - other accessories | W0580 | A IVDR | EUDAMED record Report an error | |
| Staphylococci reagents - other | W0105011299 |
|
A IVDR | EUDAMED record Report an error |
| Streptococcal reagents - other | W0105011199 | A IVDR | EUDAMED record Report an error | |
| Various microbiology instruments - software accessories | W02039082 | B IVDR | EUDAMED record Report an error |
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