Panels › Microbiology › Product code LGD · Class 2
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Regulation 866.3780
0510(k)s in 12 months (106 all time)
0recalls in 12 months (7 all time)
4recalls that name a 510(k)
Top companies in LGD
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 28, 2025 | K242022 | Access Toxo IgG Beckman Coulter, Inc. | LGD |
| Oct 11, 2024 | K242095 | Access Toxo IgM II Beckman Coulter, Inc. | LGD |
| Aug 30, 2024 | K233932 | Alinity i Toxo IgM Abbott Laboratories | LGD |
| May 19, 2022 | K210596 | ARCHITECT Toxo IgG Abbott Laboratories | LGD |
| Jun 23, 2017 | K162678 | Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl Roche Diagnostics | LGD |
| Dec 22, 2015 | K142826 | ADVIA Centaur Toxoplasma M (Toxo M) Siemens Healthcare Diagnostics, Inc. | LGD |
| Aug 28, 2013 | K132234 | LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II DiaSorin, Inc. | LGD |
| Aug 9, 2013 | K131441 | LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II DiaSorin, Inc. | LGD |
| May 18, 2011 | K101946 | VIDAS TOXO IGG AVIDITY bioMerieux, Inc. | LGD |
| May 4, 2011 | K102681 | ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) Siemens Healthcare Diagnostics, Inc. | LGD |
| Jul 1, 2009 | K090847 | PLATELIA TOXO IGM KIT MODEL 26211 Bio-Rad Laboratories | LGD |
| Jun 9, 2008 | K073501 | ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG Roche Diagnostics Corp. | LGD |
| May 23, 2008 | K080869 | ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC Beckman Coulter, Inc. | LGD |
| Feb 8, 2006 | K052499 | DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS Diasorin S.P.A | LGD |
| Aug 8, 2003 | K032162 | ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY Beckman Coulter, Inc. | LGD |
| Jun 2, 2003 | K031506 | ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY Beckman Coulter, Inc. | LGD |
| Sep 30, 2002 | K013839 | BIO-RAD PLATELIA TOXO IGG TMB Bio-Rad | LGD |
| Sep 30, 2002 | K013837 | BIO-RAD PLATELIA TOXO IGM TMB Bio-Rad | LGD |
| Jan 10, 2002 | K012075 | IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6 Diagnostic Products Corp. | LGD |
| Dec 27, 2001 | K012183 | BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY Bayer Diagnostics Corp. | LGD |
| Aug 20, 2001 | K010755 | BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY Bayer Corp. | LGD |
| Jun 13, 2001 | K003259 | ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479 Beckman Coulter, Inc. | LGD |
| Aug 31, 2000 | K002453 | ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479 Beckman Coulter, Inc. | LGD |
| Jul 7, 2000 | K001707 | DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM Diamedix Corp. | LGD |
| May 22, 2000 | K993319 | VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 bioMerieux, Inc. | LGD |
| Jan 22, 1999 | K984317 | THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)F Zeus Scientific, Inc. | LGD |
| Jan 19, 1999 | K984170 | THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGM ELISA TEST SYSTEM Zeus Scientific, Inc. | LGD |
| Sep 17, 1998 | K973448 | ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469 Beckman Instruments, Inc. | LGD |
| Aug 21, 1998 | K981498 | IS-TOXOPLASMA IGG TEST SYSTEM Diamedix Corp. | LGD |
| Dec 2, 1997 | K971441 | QUANTA LITE TOXOPLASMA IGG Inova Diagnostics, Inc. | LGD |
| Oct 22, 1997 | K971989 | TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) Bayer Corp. | LGD |
| Oct 21, 1997 | K971672 | SERAQUEST TOXOPLASMA IGM Quest Intl., Inc. | LGD |
| May 1, 1997 | K963289 | INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY Incstar Corp. | LGD |
| Apr 24, 1997 | K962936 | IMMULITE TOXOPLASMA QUANTITATIVE IGG Diagnostic Products Corp. | LGD |
| Mar 24, 1997 | K962343 | TOXO IGG ELISA TEST Gull Laboratories, Inc. | LGD |
| Dec 16, 1996 | K963297 | INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560) Incstar Corp. | LGD |
| Dec 16, 1996 | K963296 | INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565) Incstar Corp. | LGD |
| Aug 23, 1996 | K954576 | AXSYM TOXO IGM Abbott Laboratories | LGD |
| Aug 16, 1996 | K954575 | AXSYM TOXO IGG ANTIBODY ASSAY Abbott Laboratories | LGD |
| Aug 2, 1996 | K955760 | TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM Bayer Corp. | LGD |
| Jun 17, 1996 | K960092 | SERAQUEST TOXOPLASMA IGG Quest Intl., Inc. | LGD |
| May 14, 1996 | K944867 | TOXOSTAT Bio-Whittaker, Inc., A Cambrex Co. | LGD |
| Feb 23, 1996 | K950671 | IMMULITE TOXOPLASMA GONDII IGG Diagnostic Products Corp. | LGD |
| Dec 20, 1995 | K951495 | ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM Bio-Rad Laboratories, Inc. | LGD |
| Aug 1, 1995 | K951636 | IMX TOXO IGG Abbott Laboratories | LGD |
| Apr 27, 1995 | K945634 | IMX(R) TOXO IGM Abbott Laboratories | LGD |
| Jun 21, 1993 | K931334 | VIDAS TOXO COMPETITION (TXC) ASSAY Biomerieux Vitek, Inc. | LGD |
| May 11, 1993 | K922737 | VIDAS TOXO IG6 ASSAY (TX6) Biomerieux Vitek, Inc. | LGD |
| Feb 25, 1993 | K923166 | VIDAS TOXOPLASMA GONDII IGM ASSSAY Biomerieux Vitek, Inc. | LGD |
| Sep 14, 1992 | K921523 | OPUS(R) TOXO-G TEST SYSTEM Pb Diagnostics, Inc. | LGD |
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