ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT)

ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT) is an FDA 510(k)-cleared medical device (K854017) manufactured by Lmd Laboratories. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 21, 1985. Regulation: 8.