ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT

ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT is an FDA 510(k)-cleared medical device (K983694) 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 4, 1999. Regulation: 8.