Applied BioCode received expanded FDA 510(k) clearance for its BioCode Respiratory Pathogen Panel (RPP) workflow to incorporate automated extraction using Thermo Fisher Scientific’s KingFisher Flex platform. The cleared workflow pairs the RPP with BioCode’s MDx-3000 automated detection system. The company said the integrated platform targets 17 prevalent respiratory pathogens and is designed to help clinical laboratories optimize workflow efficiency and deliver timelier results. Applied BioCode submitted the RPP for expanded clearance in December and previously obtained expanded clearance for its gastrointestinal pathogen panel paired with the same KingFisher Flex system.
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