Device typeEntamoeba histolytica antigen IVD, kit, enzyme immunoassay (EIA): A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Entamoeba histolytica in a clinical specimen using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Entamoeba histolytica, the parasitic protozoan associated with amoebiasis.
FDA categoryIndirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp
Device ID00813545025403
Catalog numberEH-96C
Single useYes
MRI safetyLabeling does not contain MRI Safety Information