LGD
- Product code
- LGD
- Device name
- Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.3780
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 106 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242022 | 2025-03-28 | Beckman Coulter, Inc. | Access Toxo IgG | |
| K242095 | 2024-10-11 | Beckman Coulter, Inc. | Access Toxo IgM II | FDA |
| K233932 | 2024-08-30 | Abbott Laboratories | Alinity i Toxo IgM |
Official FDA classification page: LGD
Classification and pathway per current FDA publications. Data from openFDA (CC0).