MIZ

Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum

Product code: MIZ
Device name: Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum
Device class: Class 2
21 CFR: 21 CFR 866.3320
Medical specialty: Microbiology
Marketing pathway: 510(K) Exempt
510(k) clearances (all years, FDA): 2 (all years; only the last 3 years are listed here)

Official FDA classification page: MIZ

Classification and pathway per current FDA publications. Data from openFDA (CC0).