REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT

REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT is an FDA 510(k)-cleared medical device (K013077) manufactured by Corgenix, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 27, 2001. Regulation: 8.