Details
Device typeMultiple-genus respiratory virus 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 multiple virus genera associated with respiratory disease in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.
FDA categoryCovid-19 Multi-Analyte Antigen Device
Device ID20850044118452
AvailabilityOver the counter
Single useYes
MRI safetyLabeling does not contain MRI Safety Information