trending Market Intelligence /marketintelligence/en/news-insights/trending/CNq6-eX2xeY8MxJeTzDquQ2 content esgSubNav
In This List

US FDA grants clearance, waiver to Quidel's flu-detection test

Blog

Baird Research is Now Exclusively Available in S&P Global’s Aftermarket Research Collection

Blog

Japan M&A By the Numbers: Q4 2023

Blog

Essential IR Insights Newsletter Fall - 2023

Case Study

A Corporation Clearly Pinpoints Activist Investor Activity


US FDA grants clearance, waiver to Quidel's flu-detection test

The U.S. FDA granted a 510(k) clearance and a clinical laboratory improvements amendments waiver to Quidel Corp.'s Sofia Influenza A+B Fluorescent Immunoassay.

The regulator granted the clearance for the immunoassay to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for quick differential detection of influenza types A and B from direct nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens and nasopharyngeal swab and nasopharyngeal aspirate/wash specimens in transport media from symptomatic patients.

The Sofia Influenza A+B assay has improved lateral flow and immunofluorescence technologies to provide better clinical sensitivity for influenza A or B infections.