LJM

Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

Product code: LJM
Device name: Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Device class: Class 2
21 CFR: 21 CFR 866.5100
Medical specialty: Immunology
Marketing pathway: 510(K)
Flag: Third-party review eligible
510(k) clearances (all years, FDA): 112 (all years; only the last 3 years are listed here)

Official FDA classification page: LJM

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