Home › Device types › LGD
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
FDA product code LGD · Class 2 · Microbiology
64
Registered devices
1,578
Adverse events
7
Recalls
106
510(k) clearances
Devices with this code
Bio-Rad Laboratories, Inc. — Bio-RAD Laboratories, Inc.Trinity Biotech — CLARK LABORATORIES, INC.Toxo IgM AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.Alinity — Abbott GmbHDiamedix — DIAMEDIX CORPORATIONTrinity Biotech — CLARK LABORATORIES, INC.Alinity — Abbott GmbHTrinity Biotech — CLARK LABORATORIES, INC.Access Toxo IgM II Calibrators — Beckman Coulter, Inc.SeraQuest — QUEST INTERNATIONAL, INC.Alinity — Abbott GmbHAccess Toxo IgG Calibrators — Beckman Coulter, Inc.ADVIA Centaur® Toxo G — Siemens Healthcare Diagnostics Inc.Atellica IM Toxo G — Siemens Healthcare Diagnostics Inc.Pointe Scientific, Inc. Toxoplasma IgM — HORIBA INSTRUMENTS INCORPORATEDAtellica IM Toxo M — Siemens Healthcare Diagnostics Inc.Gold Standard Diagnostics Is-Toxoplasma IgG ELISA Test Kit — Gold Standard Diagnostics CorporationASI Toxoplasma IgG EIA Test — ARLINGTON SCIENTIFIC, INC.VIDAS® TOXO Compétition — BIOMERIEUX SAPLATELIA — BIO-RADADVIA Centaur® Toxo G QC — Siemens Healthcare Diagnostics Inc.Alinity — Abbott GmbHElecsys Toxo IgG Immunoassay — Roche Diagnostics GmbHTrinity Biotech — CLARK LABORATORIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-30 | Bio-Rad Laboratories, Inc. | Due to a risk of false positive results that could lead to unnecessary medical treatment. |
| 2021-09-22 | bioMerieux, Inc. | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote |
| 2018-03-23 | BioMerieux SA | A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA as |
| 2010-12-22 | BioCheck Inc | Product labels indicate that the products are for IVD use and they do not have an approved 510(k). |
| 2008-08-27 | Calbiotech Inc | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard rel |
| 2007-04-23 | Abbott Laboratories | Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placem |
| 2007-04-23 | Abbott Laboratories | Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placem |
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