LGD · Class II · 21 CFR 866.3780

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 and Beckman Coulter, Inc..

4
Total
4
Cleared
263d
Avg days
2022
Since

List of Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii devices cleared through 510(k)

4 devices
1–4 of 4
Cleared Mar 28, 2025
Access Toxo IgG
K242022
Beckman Coulter, Inc.
Microbiology · 260d
Cleared Oct 11, 2024
Access Toxo IgM II
K242095
Beckman Coulter, Inc.
Microbiology · 86d
Cleared Aug 30, 2024
Alinity i Toxo IgM
K233932
Abbott Laboratories
Microbiology · 260d
Cleared May 19, 2022
ARCHITECT Toxo IgG
K210596
Abbott Laboratories
Microbiology · 444d

How to use this database

This page lists all FDA 510(k) submissions for Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii devices (product code LGD). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →