VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210

VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 is an FDA 510(k)-cleared medical device (K993319) manufactured by bioMerieux, 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 May 21, 2000. Regulation: 8.