VARELISA HELICOBACTER PYLORI ANTIBODIES

VARELISA HELICOBACTER PYLORI ANTIBODIES is an FDA 510(k)-cleared medical device (K953873) manufactured by Elias U.S.A., Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 29, 1996. Regulation: 8.