Applied BioCode Unit Gets US FDA Nod for Respiratory Pathogen Panel

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Applied BioCode's (TPE:6598) US unit has secured a 510(k) clearance from the U.S. FDA for its respiratory pathogen panel, according to a Monday Taiwan Exchange filing.

The approval allows the panel to be used with the BioCode MDx 3000 system alongside Thermo Fisher Scientific's KingFisher extraction platform, adding to existing compatibility with systems from bioMérieux and Roche.

The company said the clearance enables sales of the combined solution in the US, offers labs greater flexibility in extraction systems, and is expected to support its business and financial performance.

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