CD138 cell marker IVD, antibody

CD138 cell marker in vitro diagnostic (IVD) devices use antibodies to detect the presence or measure the quantity of CD138 proteins in clinical samples, such as blood or tissue. These tests are primarily used in diagnostics to support the identification of conditions like multiple myeloma or other plasma cell disorders, aiding in disease monitoring and treatment planning.

These devices are typically regulated as IVDs, with classification and supply depending on the jurisdiction and intended use. They are designed for laboratory use and may require validation for clinical accuracy, though specific regulatory pathways vary by country. Always check local guidelines for compliance and approval requirements.