VIDAS TOXO COMPETITION (TXC) ASSAY

VIDAS TOXO COMPETITION (TXC) ASSAY is an FDA 510(k)-cleared medical device (K931334) manufactured by Biomerieux Vitek, 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 June 20, 1993. Regulation: 8.