LGI — Fluorescence Polarization Immunoassay, Carbamazepine Class II

FDA Device Classification

FDA product code LGI covers "Fluorescence Polarization Immunoassay, Carbamazepine", a Class II medical device regulated under 21 CFR 862.3645. Submissions are reviewed by the Clinical Toxicology panel. At least 3 recent 510(k) clearances have been granted under this product code.