RAPIRUN H. PYLORI ANTIBODY DETECTION KIT

RAPIRUN H. PYLORI ANTIBODY DETECTION KIT is an FDA 510(k)-cleared medical device (K052716) manufactured by Otsuka Pharmaceutical Co., Ltd.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 15, 2006. Regulation: 8.