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FDA approves Quidel immunoassay systems

The US Food and Drug Administration (FDA) has granted a 510(k) approval to Quidel's Sofia Analyzer and Sofia Influenza A+B fluorescent immunoassay (FIA) test.

The Sofia Analyzer and Influenza A+B FIA unites software and fluorescent chemistry to yield an automatic, objective result.

The results are readily available on the instrument’s screen, in a hard-copy printout, and in a transmissible electronic form that can network via an LIS system to hospital and medical center databases.

The Sofia FIA applies advanced lateral flow and immunofluorescence technologies to provide enhanced clinical sensitivity for influenza A and B.