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# Quidel Gains Clearance for Sofia RSV Immunoassay
- URL: https://www.fdaweb.com/quidel-gains-clearance-for-sofia-rsv-immunoassay/
- Published: 2017-06-28T12:00:00.000Z
- Updated: 2026-09-14T22:32:05.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139050

FDA has cleared a Quidel510(k) for the Sofia RSV Fluorescent Immunoassay to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid detection of respiratory syncytial virus infections in nasopharyngeal swab and nasopharyngeal aspirate/wash specimens taken directly from symptomatic pediatric patients. The company says Sofia 2 is its next-generation version of its instrumented system and uses the original fluorescent chemistry design while improving upon the graphical user interface and optics system to provide a result within three minutes. Sofia 2 also integrates wireless connectivity and its barcode scanner within a smaller footprint than the legacy Sofia instrument, it says.