GTH — Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae Class II

FDA Device Classification

FDA product code GTH covers "Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae", a Class II medical device regulated under 21 CFR 866.3390. Submissions are reviewed by the Microbiology panel. At least 3 recent 510(k) clearances have been granted under this product code.