AXSYM TOXO IGG ANTIBODY ASSAY

AXSYM TOXO IGG ANTIBODY ASSAY is an FDA 510(k)-cleared medical device (K954575) manufactured by Abbott Laboratories. 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 15, 1996. Regulation: 8.