Details
Device typeSARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing: A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.
FDA categoryOver-The-Counter Covid-19 Antigen Test
Device ID50856362005901
AvailabilityOver the counter
Single useYes
MRI safetyLabeling does not contain MRI Safety Information