CD38 cell marker IVD, antibody

CD38 cell marker IVD antibodies are laboratory reagents designed to identify and measure CD38 proteins in biological samples, such as blood or bone marrow. Clinically, these devices help diagnose, monitor, or assess conditions like multiple myeloma, chronic lymphocytic leukemia, and other hematologic disorders by detecting CD38 expression levels on cells.

These diagnostic tools are typically regulated as in vitro diagnostics (IVDs) and may require compliance with standards like ISO 13485 or FDA 21 CFR Part 820, depending on the jurisdiction. They are usually supplied as kits, reagents, or conjugated antibodies for use in flow cytometry, immunohistochemistry, or other laboratory assays, ensuring precise and reliable test results.