21 devices · GMDN 48316
This category comprises in‑vitro diagnostic kits that contain reagents and related materials for detecting total antibodies against the hepatitis B virus surface antigen in patient samples, using a chemiluminescent immunoassay technique. The tests can provide either qualitative or quantitative results to help assess immunity or past infection.
These kits are regulated as IVD devices and are typically supplied as complete assay kits ready for laboratory use. Their regulatory classification varies by market, and manufacturers must meet the applicable IVD requirements for safety, performance, and labeling.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.