CD43 cell marker IVD, antibody

CD43 cell marker in vitro diagnostic (IVD) antibodies are laboratory reagents designed to identify and measure CD43 proteins in biological samples. Clinically, these devices help diagnose or monitor conditions linked to CD43 expression, such as certain leukemias or immune system disorders, by detecting its presence in cells like lymphocytes or other specimens.

These antibodies are typically supplied as ready-to-use kits, conjugates, or reagents for immunoassays, flow cytometry, or immunohistochemistry. Regulation varies by jurisdiction, but they are generally classified as high-risk medical devices due to their role in diagnostic testing, requiring compliance with IVD-specific standards and manufacturing controls.