GTX — Antisera, Fluorescent, All Groups, Streptococcus Spp. Class I

FDA Device Classification

FDA product code GTX covers "Antisera, Fluorescent, All Groups, Streptococcus Spp.", a Class I medical device regulated under 21 CFR 866.3740. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.