GWD — Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp Class II

FDA Device Classification

FDA product code GWD covers "Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp", a Class II medical device regulated under 21 CFR 866.3220. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.