p40 protein IVD, antibody

This category includes in vitro diagnostic (IVD) devices designed to detect the presence or measure levels of the p40 protein, a component of certain antigens. Clinically, these tests help identify infections, monitor disease progression, or support diagnostic decisions in conditions where p40 protein is relevant, such as tuberculosis or specific cancers.

Devices in this category are typically regulated as IVDs, with classification and supply depending on their intended use and risk level. They may be supplied as reagents, kits, or automated systems, often requiring validation for accuracy and performance in clinical settings. Regulations vary by jurisdiction, but all must meet standards for safety, reliability, and proper labeling.