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NEW YORK (360Dx) – Quidel said on Tuesday that the US Food and Drug Administration has given 510(k) clearance and a CLIA waiver for its Sofia Influenza A+B fluorescent immunoassay operating on the Sofia 2 analyzer.

The combination is cleared for use in the rapid, 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, Quidel said.

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