Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

This category includes in vitro diagnostic kits designed to detect immunoglobulin G (IgG) antibodies specific to Toxoplasma gondii in patient samples. These tests use enzyme immunoassay (EIA) technology to support the clinical assessment of past or current infection with this parasitic protozoan, which can cause toxoplasmosis, particularly important in prenatal and immunocompromised patient evaluations.

Devices in this category are supplied as kits containing reagents and necessary materials for performing the assay. They are intended for use in clinical laboratories and are regulated as in vitro diagnostic medical devices, with their classification and conformity assessment based on the intended use and risk profile as defined in applicable regulatory frameworks.