BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT

BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT is an FDA 510(k)-cleared medical device (K991802) 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 May 4, 2000. Regulation: 8.