HUMAN IGA SUBCLASS BNII COMBI KIT

HUMAN IGA SUBCLASS BNII COMBI KIT is an FDA 510(k)-cleared medical device (K981912) 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 3, 1998. Regulation: 8.