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Quidel secures FDA clearance, CLIA waiver for RSV assay on analyzer

The FDA has given Quidel clearance for its Sofia RSV Fluorescent Immunoassay for use on the Sofia 2 Fluorescent Immunoassay Analyzer in rapid respiratory syncytial virus infection detection. The assay, which also received a CLIA waiver, is indicated to be used in nasopharyngeal aspirate/wash and nasopharyngeal swab specimens from symptomatic pediatric patients.

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