GNH — Antigen, Fluorescent Antibody Test, Schistosoma Mansoni Class I

FDA Device Classification

FDA product code GNH covers "Antigen, Fluorescent Antibody Test, Schistosoma Mansoni", a Class I medical device regulated under 21 CFR 866.3600. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.