BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT

BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT is an FDA 510(k)-cleared medical device (K042579) manufactured by The Binding Site. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 27, 2005. Regulation: 8.