LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set

LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set is an FDA 510(k)-cleared medical device (K192046) 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 October 27, 2019. Regulation: 8.