GRO — Antisera, Fluorescent, All Types, Hemophilus Spp. Class II

FDA Device Classification

FDA product code GRO covers "Antisera, Fluorescent, All Types, Hemophilus Spp.", a Class II medical device regulated under 21 CFR 866.3300. Submissions are reviewed by the Microbiology panel. At least 4 recent 510(k) clearances have been granted under this product code.