Applied BioCode received expanded FDA 510(k) clearance for its BioCode Respiratory Pathogen Panel, adding automated extraction using Thermo Fisher Scientific’s KingFisher Flex platform. The cleared workflow pairs the panel with Applied BioCode’s MDx-3000 automated detection system. The company said the combined system supports detection of 17 prevalent respiratory pathogens and is aimed at reducing operational friction for clinical labs. With earlier clearance already granted for its gastrointestinal pathogen panel paired with KingFisher Flex, the regulatory update strengthens Applied BioCode’s push into high-throughput multiplex workflows.
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