HUMAN IGD KIT FOR USE ON SPAPLUS

HUMAN IGD KIT FOR USE ON SPAPLUS is an FDA 510(k)-cleared medical device (K092450) 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 December 27, 2009. Regulation: 8.