CorDx antigen test kit home test OTC EUA

The CorDx COVID-19 Ag Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid

protein antigen from the SARS-CoV-2 virus.

This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological

reasons to suspect COVID-19, when tested at least three times over five

days with at least 48 hours between tests.