ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC)

ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC) is an FDA 510(k)-cleared medical device (K844141) 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 December 5, 1984. Regulation: 8.