LIAISON PLEX Gastrointestinal Flex Assay

LIAISON PLEX Gastrointestinal Flex Assay is an FDA 510(k)-cleared medical device (K253722) manufactured by Luminex Corporation. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 18, 2026. Regulation: 8.