DeviceClearance

Product code LGD— Microbiology

TOXO IGG ELISA TEST

Classification name
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Device class
Class 2
Regulation
21 CFR 866.3780
Advisory panel
Microbiology
Total cleared
106
First cleared
Most recent

Market context for product code LGD

FDA has cleared 106 devices under product code LGD between 1982 and 2025, filed by 51 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code LGD

Adverse events under product code LGD

product code LGD
Malfunction
502
Total
502

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code LGD

1–100 of 106

Data sourced from openFDA. This site is unofficial and independent of the FDA.