PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI

PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI is an FDA 510(k)-cleared medical device (K001177) manufactured by Enteric Products, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 12, 2000. Regulation: 8.