IS H. PYLORI IGG ELISA TEST SYSTEM

IS H. PYLORI IGG ELISA TEST SYSTEM is an FDA 510(k)-cleared medical device (K990462) manufactured by Columbia Bioscience, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 2, 1999. Regulation: 8.