SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT

SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT is an FDA 510(k)-cleared medical device (K002560) 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 October 25, 2000. Regulation: 8.