Device typeMultiple-genus respiratory virus antigen IVD, reagent: A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from multiple virus genera associated with respiratory diseases in a clinical specimen. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.
FDA categoryRespiratory Syncytial Virus, Antigen, Antibody, Ifa
Device ID05056080501758
MRI safetyLabeling does not contain MRI Safety Information