UNICAP GLIADIN IGA ASSAY

UNICAP GLIADIN IGA ASSAY is an FDA 510(k)-cleared medical device (K982533) manufactured by Pharmacia & Upjohn Co.. 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 21, 1998. Regulation: 8.