FebriDx Bacterial/Non-bacterial Assay

FebriDx Bacterial/Non-bacterial Assay is an FDA 510(k)-cleared medical device (K260787) manufactured by Lumos Diagnostics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 23, 2026. Regulation: 8.