Details
Device typeInfluenza A/B virus antigen IVD, kit, rapid ICT, clinical: A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from influenza A virus and/or influenza B virus 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 used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
FDA categoryDevices Detecting Influenza A, B, And C Virus Antigens
Device ID00695684744250
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information