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Sofia Strep A+ Assay lands FDA 510(k) clearance

Jan. 5, 2018Quidel received 510(k) clearance and CLIA waiver from the FDA for its Sofia Strep A+ Fluorescent Immunoassay (FIA) for use with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid detection of infections by group A streptococcus bacteria. Sofia Strep A+ is the third CLIA-waived assay available on the Sofia 2 system, following the Sofia Influenza A+B and Sofia RSV assays.

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