FDA granted a CLIA waiver to Quidel's Sofia Influenza A+B Fluorescent Immunoassay (FIA) for detection of influenza A and B infection and its Sofia Fluorescent Immunoassay Analyzer. The immunoassay, which has CE Mark approval, is...

FDA granted 510(k) clearance to Quidel's Sofia Influenza A+B Fluorescent Immunoassay to detect influenza A and B infection. The assay will be available immediately in the U.S. and has CE Mark approval. The immunoassay uses...

Quidel said it received CE Mark approval for its Sofia Influenza A+B Fluorescent Immunoassay to detect influenza A and B infection. The immunoassay uses lateral flow technology coupled with fluorescence to detect antibodies against the...