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