Product code LGD
- Device name
- Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3780
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242022 | Access Toxo IgG | Beckman Coulter, Inc. | 2025-03-28 |
| K242095 | Access Toxo IgM II | Beckman Coulter, Inc. | 2024-10-11 |
| K233932 | Alinity i Toxo IgM | Abbott Laboratories | 2024-08-30 |
| K210596 | ARCHITECT Toxo IgG | Abbott Laboratories | 2022-05-19 |
| K162678 | Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl | Roche Diagnostics | 2017-06-23 |
| K142826 | ADVIA Centaur Toxoplasma M (Toxo M) | Siemens Healthcare Diagnostics, Inc. | 2015-12-22 |
| K132234 | LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II | DiaSorin, Inc. | 2013-08-28 |
| K131441 | LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II | DiaSorin, Inc. | 2013-08-09 |
| K101946 | VIDAS TOXO IGG AVIDITY | bioMerieux, Inc. | 2011-05-18 |
| K102681 | ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) | Siemens Healthcare Diagnostics, Inc. | 2011-05-04 |
| K090847 | PLATELIA TOXO IGM KIT MODEL 26211 | Bio-Rad Laboratories | 2009-07-01 |
| K073501 | ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG | Roche Diagnostics Corp. | 2008-06-09 |
| K080869 | ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC | Beckman Coulter, Inc. | 2008-05-23 |
| K052499 | DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS | Diasorin S.P.A | 2006-02-08 |
| K032162 | ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY | Beckman Coulter, Inc. | 2003-08-08 |
| K031506 | ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY | Beckman Coulter, Inc. | 2003-06-02 |
| K013837 | BIO-RAD PLATELIA TOXO IGM TMB | Bio-Rad | 2002-09-30 |
| K013839 | BIO-RAD PLATELIA TOXO IGG TMB | Bio-Rad | 2002-09-30 |
| K012075 | IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6 | Diagnostic Products Corp. | 2002-01-10 |
| K012183 | BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY | Bayer Diagnostics Corp. | 2001-12-27 |
| K010755 | BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY | Bayer Corp. | 2001-08-20 |
| K003259 | ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479 | Beckman Coulter, Inc. | 2001-06-13 |
| K002453 | ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479 | Beckman Coulter, Inc. | 2000-08-31 |
| K001707 | DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM | Diamedix Corp. | 2000-07-07 |
| K993319 | VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 | bioMerieux, Inc. | 2000-05-22 |
| K984317 | THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)F | Zeus Scientific, Inc. | 1999-01-22 |
| K984170 | THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGM ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1999-01-19 |
| K973448 | ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469 | Beckman Instruments, Inc. | 1998-09-17 |
| K981498 | IS-TOXOPLASMA IGG TEST SYSTEM | Diamedix Corp. | 1998-08-21 |
| K971441 | QUANTA LITE TOXOPLASMA IGG | Inova Diagnostics, Inc. | 1997-12-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00380740189976 | Alinity | Abbott GmbH | 2025-04-08 |
| 00380740190002 | Alinity | Abbott GmbH | 2025-04-08 |
| 00380740200626 | Alinity | Abbott GmbH | 2025-04-08 |
| 00380740200633 | Alinity | Abbott GmbH | 2025-04-08 |
| 00816870024134 | Toxo IgM AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870024127 | Toxo IgM AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870024097 | Toxo IgG AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870024080 | Toxo IgG AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2024-09-13 |
| 07613336218464 | Elecsys Toxo IgM | Roche Diagnostics GmbH | 2024-08-13 |
| 00850054026002 | QMedix™ | Diagnostic Automation, Inc. | 2024-02-02 |
| 00850049545662 | AccuDiag ™ | Diagnostic Automation, Inc. | 2023-06-14 |
| B3507203000 | Gold Standard Diagnostics Is-Toxoplasma IgG ELISA Test Kit | Gold Standard Diagnostics Corporation | 2022-12-05 |
| 00380740203177 | Alinity | Abbott GmbH | 2022-11-26 |
| 00380740174361 | Alinity | Abbott GmbH | 2022-11-26 |
| 00380740174354 | Alinity | Abbott GmbH | 2022-11-26 |
| 05391516746823 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-12-26 |
| 05391516747479 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-12-26 |
| 03610521167488 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2017-08-05 |
| 03610520150269 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2017-08-05 |
| 03610520992715 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2017-08-05 |
| 04015630940318 | Elecsys Toxo IgM | Roche Diagnostics GmbH | 2017-07-31 |
| 04015630921485 | Elecsys Toxo IgM | Roche Diagnostics GmbH | 2017-07-31 |
| 04015630940301 | Elecsys Toxo IgG | Roche Diagnostics GmbH | 2017-04-21 |
| 04015630939336 | Elecsys Toxo IgG Immunoassay | Roche Diagnostics GmbH | 2016-09-20 |
| 15099590624781 | Access Toxo IgM II QC | Beckman Coulter, Inc. | 2016-09-09 |
| 03573026156862 | VIDAS® TOXO Compétition | BIOMERIEUX SA | 2016-08-31 |
| 03573026263010 | VIDAS® TOXOIgG AVIDITY | BIOMERIEUX SA | 2016-08-31 |
| 03573026156855 | VIDAS® TOXO IgG II | BIOMERIEUX SA | 2016-08-31 |
| 03573026156824 | VIDAS® TOXO IgM | BIOMERIEUX SA | 2016-08-31 |
| 03610520007853 | PLATELIA | BIO-RAD | 2016-08-16 |