LGD — Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Class II
FDA product code LGD covers "Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii", a Class II medical device regulated under 21 CFR 866.3780. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LGD
- Device Class
- Class II
- Regulation Number
- 866.3780
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242022 | beckman coulter | Access Toxo IgG | March 28, 2025 |
| K242095 | beckman coulter | Access Toxo IgM II | October 11, 2024 |
| K233932 | abbott laboratories | Alinity i Toxo IgM | August 30, 2024 |
| K210596 | abbott laboratories | ARCHITECT Toxo IgG | May 19, 2022 |
| K162678 | roche diagnostics | Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl | June 23, 2017 |
| K142826 | siemens healthcare diagnostics | ADVIA Centaur Toxoplasma M (Toxo M) | December 22, 2015 |
| K132234 | diasorin | LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II | August 28, 2013 |
| K131441 | diasorin | LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II | August 9, 2013 |
| K101946 | biomerieux | VIDAS TOXO IGG AVIDITY | May 18, 2011 |
| K102681 | siemens healthcare diagnostics | ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) | May 4, 2011 |
| K090847 | bio-rad laboratories | PLATELIA TOXO IGM KIT MODEL 26211 | July 1, 2009 |
| K073501 | roche diagnostics | ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG | June 9, 2008 |
| K080869 | beckman coulter | ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC | May 23, 2008 |
| K052499 | diasorin | DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS | February 8, 2006 |
| K032162 | beckman coulter | ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY | August 8, 2003 |
| K031506 | beckman coulter | ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY | June 2, 2003 |
| K013837 | bio-rad | BIO-RAD PLATELIA TOXO IGM TMB | September 30, 2002 |
| K013839 | bio-rad | BIO-RAD PLATELIA TOXO IGG TMB | September 30, 2002 |
| K012075 | diagnostic products | IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MO | January 10, 2002 |
| K012183 | bayer diagnostics | BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY | December 27, 2001 |