| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA | 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) |
| Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA | 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) |
| Sofia Lyme FIA; Sofia 2 Campylobacter FIA | 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) |
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