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Medical Devices / Submissions and Approvals

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

May 26, 2017
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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

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