Manufacturer
BioFire Diagnostics
United StatesLegal entities : BioFire Diagnostics, LLC
Markets : France · United States
Approvals : EU – class A, B, C, D · United States (FDA) – 510(k) : 39 · class II · latest in 2026 · see on the FDA website
EU representative : bioMérieux SA (France)
- 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 |
|---|---|---|---|---|
| Nucleic acid testing integrated extraction /amplification /detection systems | W02050116 | A IVDR | EUDAMED record Report an error | |
| Gastrointestinal infections - multiplex NA reagents | W0105070504 | B IVDR | EUDAMED record Report an error | |
| Respiratory tract infections - multiplex NA reagents | W0105070503 | D IVDR | EUDAMED record Report an error | |
| Gram+ - gram- - fungi - multiplex assays | W0105070203 | C IVDR | EUDAMED record Report an error | |
| Meningitis / encephalitis infections - multiplex NA reagents | W0105070505 | C IVDR | EUDAMED record Report an error | |
| Other multiple infectious - multiplex NA reagents | W0105070502 | C IVDR | EUDAMED record Report an error | |
| Tropical fever - multiplex NA reagents | W0105070506 | C IVDR | EUDAMED record Report an error |
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