LIAISON HAV IgM, LIAISON Control HAV IgM

LIAISON HAV IgM, LIAISON Control HAV IgM is an FDA 510(k)-cleared medical device (K160650) manufactured by DiaSorin, 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 August 24, 2016. Regulation: 8.