
Pharmacia Diagnostics AB
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IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02 is an FDA 510(k)-cleared medical device (K052793) manufactured by Pharmacia Diagnostics AB. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 6, 2006. Regulation: 8.