LIAISON PLEX Respiratory Flex Assay

LIAISON PLEX Respiratory Flex Assay is an FDA 510(k)-cleared medical device (K233410) 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 February 29, 2024. Regulation: 8.