Alinity m Resp-4-Plex

Alinity m Resp-4-Plex is an FDA 510(k)-cleared medical device (K241573) manufactured by Abbott Molecular, 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 February 13, 2025. Regulation: 8.