HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER

HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER is an FDA 510(k)-cleared medical device (K082129) 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 February 9, 2009. Regulation: 8.