Device typeMultiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay: A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from multiple virus genera associated with respiratory diseases in a clinical specimen, using a fluorescent immunoassay method. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.
FDA categoryCOVID-19 Multi-Analyte Antigen Device
Device ID30014613339229
Catalog number20377
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information