GRY — Antigens, All, Leptospira Spp. Class II

FDA Device Classification

FDA product code GRY covers "Antigens, All, Leptospira Spp.", a Class II medical device regulated under 21 CFR 866.3350. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.