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Quidel gets FDA clearance, CLIA waiver for influenza assay on analyzer

The FDA has granted Quidel a Clinical Laboratory Improvement Amendments waiver and 510(k) clearance for its Sofia Influenza A+B fluorescent immunoassay on the Sofia 2 analyzer for use in rapid, differential influenza A and B detection. The assay provides improved clinical sensitivity for the infections using advanced lateral flow and immunofluorescence technologies, while the analyzer delivers an automated, precise result within three minutes.

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