ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY

ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY is an FDA 510(k)-cleared medical device (K112414) manufactured by Phadia US, 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 June 21, 2012. Regulation: 8.