9540 Waples Street Unit C, San Diego, CA, United States, 92121
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| CorDx Tyfast COVID-19 Ag Rapid Test Rx | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| COVID-19 Ag Test | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| Influenza A/B+COVID-19/RSV Combo Ag Test | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
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