
Euroimmun Us, Inc.
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EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA) is an FDA 510(k)-cleared medical device (K083052) manufactured by Euroimmun 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 July 27, 2009. Regulation: 8.