HUMAN IGA2 KIT FOR USE ON THE SPAPLUS

HUMAN IGA2 KIT FOR USE ON THE SPAPLUS is an FDA 510(k)-cleared medical device (K100588) manufactured by The Binding Site Group , 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 August 15, 2010. Regulation: 8.