KTS — Second Antibody (Species Specific Anti-Animal Gamma Globulin) Class II

FDA Device Classification

FDA product code KTS covers "Second Antibody (Species Specific Anti-Animal Gamma Globulin)", a Class II medical device regulated under 21 CFR 866.5510. Submissions are reviewed by the Immunology panel. At least 4 recent 510(k) clearances have been granted under this product code.