FDA Product Code LGD: Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

Toxoplasma gondii infection poses serious risks to immunocompromised patients and fetuses. FDA product code LGD covers enzyme-linked immunosorbent assay systems for Toxoplasma gondii antibody detection.

These immunoassays detect IgG and IgM antibodies against Toxoplasma gondii in serum, enabling the diagnosis of acute and past infection. IgM detection is critical in pregnant women to identify primary infection that poses a risk of congenital toxoplasmosis.

LGD devices are Class II medical devices, regulated under 21 CFR 866.3780 and reviewed by the FDA Microbiology panel.

Leading manufacturers include Abbott Laboratories, Beckman Coulter, Inc. and Gull Laboratories, Inc..