BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT

BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT is an FDA 510(k)-cleared medical device (K981929) 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 September 2, 1998. Regulation: 8.