MIZ — Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum Class II

FDA Device Classification

FDA product code MIZ covers "Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum", a Class II medical device regulated under 21 CFR 866.3320. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.