CareStart™ COVID-19 Antigen Home Test

The CareStart™ COVID-19 Antigen Home Test is a rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection when tested twice over two or three days with at least 24 hours and not more than 48 hours between tests. This test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal swab samples from individuals aged 2 years or older. CONTENTS  2 CareStartTM COVID-19 Ag Home Test Devices  2 Nasal Swabs  2 Extraction Vial Tubes   2 Extraction Vial Caps   Quick Reference Instructions & Fact Sheet for Individuals  Bullet Points HOME USE TEST AUTHORIZED BY FDA UNDER AN EUA: The CareStartTM COVID-19 Antigen Home Test is authorized for non-prescription home use with self-collected direct anterior nasal