November 2025—Molecular Designs has submitted a 510(k) premarket notification for its SimplicityDx Respiratory panel to the Food and Drug Administration. The in vitro diagnostic panel is designed for the simultaneous detection of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus. The multiplex real-time RT-PCR assay is designed to detect viral RNA in anterior nasal swabs. It includes two targets for SARS-CoV-2, one each for influenza A and B, and two for RSV, along with an internal control to validate run performance.
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