HELICOBACTER PYLORI ELISA IGG TEST KIT

HELICOBACTER PYLORI ELISA IGG TEST KIT is an FDA 510(k)-cleared medical device (K110745) manufactured by Gold Standard Diagnostics. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 1, 2012. Regulation: 8.