Manufacturer
SpeeDx
AustraliaLegal entities : SpeeDx Pty. Ltd.
Markets : Netherlands · United States
Approvals : EU – class A, B, C · United States (FDA) – · class I
EU representative : MedEnvoy Global BV (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 |
|---|---|---|---|---|
| All infectious diseases controls - NAT | W0105080808 | B IVDR | EUDAMED record Report an error | |
| Gonococcal detection by NA reagents | W0105010203 | C IVDR | EUDAMED record Report an error | |
| Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents | W0105070304 | B IVDR | EUDAMED record Report an error | |
| Other virus combinations - multiplex NA reagents | W0105070302 | B IVDR | EUDAMED record Report an error | |
| Standards and calibrators for all infections/ NAT | W0105080908 | A IVDR | EUDAMED record Report an error | |
| STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents | W0105070501 |
|
C IVDR | EUDAMED record Report an error |
| Urogenital mycoplasma detection by NA reagents | W010501080302 |
|
C IVDR | EUDAMED record Report an error |
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