
Grifols USA, LLC
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GLIADIN IGA AND GLIADIN LGA is an FDA 510(k)-cleared medical device (K113377) manufactured by Grifols USA, LLC. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 13, 2012. Regulation: 8.