PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY

PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY is an FDA 510(k)-cleared medical device (K933997) manufactured by Alexon Biomedical, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 21, 1993. Regulation: 8.