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