16 devices · GMDN 54879
This category comprises in‑vitro diagnostic kits that contain the reagents and materials needed to detect antibodies against beta‑2‑glycoprotein I in patient samples using an enzyme immunoassay. The tests can provide qualitative or quantitative results and are commonly used in the evaluation of autoimmune conditions such as antiphospholipid syndrome.
These kits are regulated as IVD devices and are supplied as complete assay packages that must be used according to the manufacturer’s instructions. Their regulatory classification and requirements differ by market, so users should verify compliance with the applicable IVD regulations before deployment.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.