Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

This category includes in vitro diagnostic (IVD) kits designed to measure the total amount of immunoglobulin E (IgE) in a patient's blood or other clinical specimen. These kits use a chemiluminescent immunoassay method to detect IgE, which is an antibody associated with allergic responses and certain immune conditions, helping clinicians assess allergic disease or parasitic infections.

Devices in this category are supplied as complete reagent kits containing all necessary components for testing and are intended for use with specific laboratory analyzers. They are regulated as in vitro diagnostic medical devices and must meet performance and safety requirements for clinical use, though individual devices may vary in classification depending on the jurisdiction.