LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II

LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II is an FDA 510(k)-cleared medical device (K132234) 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 27, 2013. Regulation: 8.