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.
