BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA

BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA is an FDA 510(k)-cleared medical device (K993612) manufactured by The Binding Site, Ltd.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 20, 1999. Regulation: 8.