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FDA clears QuickVue Influenza A+B test

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Feb. 27, 2018Quidel announced it has received FDA 510(k) clearance for its CLIA-waived QuickVue Influenza A+B assay. The assay allows for the rapid, qualitative detection of influenza type A and type B antigens directly in nasal swab and nasopharyngeal swab specimens from symptomatic patients in approximately 10 minutes. In a clinical study, the QuickVue Influenza A+B test was shown to meet the FDA’s reclassification criteria for class II rapid influenza diagnostic tests.

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