Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay

This category includes diagnostic test kits designed to detect total antibodies against the hepatitis B virus core antigen in patient samples. These assays use a chemiluminescent immunoassay method to support the clinical assessment of hepatitis B infection status, including past or ongoing exposure.

Devices in this category are in vitro diagnostic reagents supplied as kits for use in laboratory settings. They are intended for professional use and regulated based on their intended purpose and performance characteristics, without implying any specific regulatory classification.