NEW YORK (360Dx) – Quidel said on Wednesday that  its Sofia RSV Fluorescent Immunoassay has been cleared by the US Food and Drug Administration and received CLIA waiver for use on the Sofia 2 Immunoassay Analyzer for the rapid detection of respiratory syncytial virus infections.

The assay is FDA cleared and CLIA waived for use in nasopharyngeal swab and nasopharyngeal aspirate/wash speciments taken directly from symptomatic pediatric patients.

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