LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set

LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set is an FDA 510(k)-cleared medical device (K181464) manufactured by DiaSorin, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 30, 2018. Regulation: 8.