FDAnews
www.fdanews.com/articles/181930-quidel-awarded-pmda-approval-for-its-sofia-influenza-ab-assay
ApprovedGreen.gif

Quidel Awarded PMDA Approval for Its Sofia Influenza A+B Assay

May 25, 2017

Quidel has received approval from Japan’s Pharmaceuticals and Medical Devices Agency for the Sofia Influenza A+B Fluorescent Immunoassay for use with the firm’s immunoassay analyzer.

The Sofia analyzer and Sofia influenza A+B FIA show the result on the instrument’s screen, as well as in a hard-copy printout and in a transmissible electronic form for hospital and medical center databases.

The products are currently available for sale in Japan. — Cynthia Jessup

View today's stories