Manufacturer
ZeptoMetrix
United StatesLegal entities : ZeptoMetrix LLC
Markets : Austria · Belgium · Germany · Northern Ireland · United States
Approvals : EU – class B · United States (FDA) – 510(k) : 1 · class I, II · latest in 2022 · see on the FDA website
EU representative : Emergo Europe 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 |
|---|---|---|---|---|
| Staphylococcal detection by NA reagents | W0105011203 | B IVDR | EUDAMED record Report an error | |
| C.difficile by NA reagents | W0105011804 | B IVDR | EUDAMED record Report an error | |
| Chlamydia trachomatis detection by NA reagents | W0105010117 | B IVDR | EUDAMED record Report an error | |
| Influenza & para influenza - NA reagents | W0105040504 | B 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 | |
| Norovirus - NA reagents | W0105040516 | B IVDR | EUDAMED record Report an error | |
| Strep. pneumoniae detection by NA reagents | W0105011105 | B IVDR | EUDAMED record Report an error | |
| Gonococcal detection by NA reagents | W0105010203 | B IVDR | EUDAMED record Report an error | |
| Respiratory syncytial virus (rsv) - NA reagents | W0105040505 | B IVDR | EUDAMED record Report an error |
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