Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay

This category includes in vitro diagnostic kits designed to detect carcinoembryonic antigen (CEA) in patient samples such as blood or serum. These kits use a chemiluminescent immunoassay method to measure CEA levels, which can assist in monitoring certain cancers, particularly colorectal cancer, and assessing treatment response or disease recurrence.

Devices in this category are regulated as in vitro diagnostic medical devices and are typically supplied as complete reagent kits containing all necessary components for testing. They are intended for use in clinical laboratory settings by trained professionals and must comply with applicable IVD regulations regarding performance, safety, and labeling.