MZO — Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus Class II

FDA Device Classification

FDA product code MZO covers "Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus", a Class II medical device regulated under 21 CFR 866.3169. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.