Atlas FDA

LGD

106 FDA 510(k) clearances · Product code

126 daysmedian time to decision
310 days90th percentile
106clearances measured

FDA profile

Official device name
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3780
Medical specialty
Microbiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 38 · 2022: 73 · 2023: 118 · 2024: 81 · 2025: 91 · 2026: 47
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Access Toxo IgG (K242022)Beckman Coulter, Inc.2025-03-28
Access Toxo IgM II (K242095)Beckman Coulter, Inc.2024-10-11
Alinity i Toxo IgM (K233932)Abbott Laboratories2024-08-30
ARCHITECT Toxo IgG (K210596)Abbott Laboratories2022-05-19
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl (K162678)Roche Diagnostics2017-06-23
ADVIA Centaur Toxoplasma M (Toxo M) (K142826)Siemens Healthcare Diagnostics, Inc.2015-12-22
LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II (K132234)DiaSorin, Inc.2013-08-28
LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II (K131441)DiaSorin, Inc.2013-08-09
VIDAS TOXO IGG AVIDITY (K101946)bioMerieux, Inc.2011-05-18
ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) (K102681)Siemens Healthcare Diagnostics, Inc.2011-05-04
PLATELIA TOXO IGM KIT MODEL 26211 (K090847)Bio-Rad Laboratories2009-07-01
ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG (K073501)Roche Diagnostics Corp.2008-06-09
ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC (K080869)Beckman Coulter, Inc.2008-05-23
DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS (K052499)Diasorin S.P.A2006-02-08
ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY (K032162)Beckman Coulter, Inc.2003-08-08
ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY (K031506)Beckman Coulter, Inc.2003-06-02
BIO-RAD PLATELIA TOXO IGG TMB (K013839)Bio-Rad2002-09-30
BIO-RAD PLATELIA TOXO IGM TMB (K013837)Bio-Rad2002-09-30
IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6 (K012075)Diagnostic Products Corp.2002-01-10
BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY (K012183)Bayer Diagnostics Corp.2001-12-27
BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY (K010755)Bayer Corp.2001-08-20
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479 (K003259)Beckman Coulter, Inc.2001-06-13
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479 (K002453)Beckman Coulter, Inc.2000-08-31
DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM (K001707)Diamedix Corp.2000-07-07
VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 (K993319)bioMerieux, Inc.2000-05-22
THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)F (K984317)Zeus Scientific, Inc.1999-01-22
THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGM ELISA TEST SYSTEM (K984170)Zeus Scientific, Inc.1999-01-19
ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469 (K973448)Beckman Instruments, Inc.1998-09-17
IS-TOXOPLASMA IGG TEST SYSTEM (K981498)Diamedix Corp.1998-08-21
QUANTA LITE TOXOPLASMA IGG (K971441)Inova Diagnostics, Inc.1997-12-02
TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K971989)Bayer Corp.1997-10-22
SERAQUEST TOXOPLASMA IGM (K971672)Quest Intl., Inc.1997-10-21
INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY (K963289)Incstar Corp.1997-05-01
IMMULITE TOXOPLASMA QUANTITATIVE IGG (K962936)Diagnostic Products Corp.1997-04-24
TOXO IGG ELISA TEST (K962343)Gull Laboratories, Inc.1997-03-24
INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565) (K963296)Incstar Corp.1996-12-16
INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560) (K963297)Incstar Corp.1996-12-16
AXSYM TOXO IGM (K954576)Abbott Laboratories1996-08-23
AXSYM TOXO IGG ANTIBODY ASSAY (K954575)Abbott Laboratories1996-08-16
TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM (K955760)Bayer Corp.1996-08-02
SERAQUEST TOXOPLASMA IGG (K960092)Quest Intl., Inc.1996-06-17
TOXOSTAT (K944867)Bio-Whittaker, Inc., A Cambrex Co.1996-05-14
IMMULITE TOXOPLASMA GONDII IGG (K950671)Diagnostic Products Corp.1996-02-23
ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM (K951495)Bio-Rad Laboratories, Inc.1995-12-20
IMX TOXO IGG (K951636)Abbott Laboratories1995-08-01
IMX(R) TOXO IGM (K945634)Abbott Laboratories1995-04-27
VIDAS TOXO COMPETITION (TXC) ASSAY (K931334)Biomerieux Vitek, Inc.1993-06-21
VIDAS TOXO IG6 ASSAY (TX6) (K922737)Biomerieux Vitek, Inc.1993-05-11
VIDAS TOXOPLASMA GONDII IGM ASSSAY (K923166)Biomerieux Vitek, Inc.1993-02-25
OPUS(R) TOXO-G TEST SYSTEM (K921523)Pb Diagnostics, Inc.1992-09-14
BARTELS TOXOPLASMA IGG EIA (K922585)Baxter Diagnostics, Inc.1992-09-02
BARTELS TOXOPLASMA IGM EIA (K922579)Baxter Diagnostics, Inc.1992-09-02
TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO (K920702)Pharmacia Diagnostics, Inc.1992-07-08
ENZYGNOST(R) TOXOPLASMOSIS/IGG (K913731)Behring Diagnostics, Inc.1992-04-29
TOXO IGG ELISA TEST (MODIFIED) (K915891)Gull Laboratories, Inc.1992-03-04
ENZYGNOST TOXOPLASMOSIS/IGM (K913505)Behring Diagnostics, Inc.1992-03-04
ELISA TOXO IGM (K914852)Sclavo, Inc.1992-01-23
TOXOPLASMA IGM ELISA TEST SYSTEM (K913787)Zeus Scientific, Inc.1991-12-18
ABBOTT IMX TOXO IGM POSITIVE CONTROL (K913106)Abbott Laboratories1991-11-29
OPUS(R) ROZO (K911834)Pb Diagnostic Systems, Inc.1991-08-12
ABBOTT TOXO-M EIA HIGH POSITIVE CONTROL (K910416)Abbott Laboratories1991-02-26
TOXO-CUBE (K903968)Difco Laboratories, Inc.1990-12-18
TOXO IGM ELISA TEST (K903324)Gull Laboratories, Inc.1990-10-16
TOXOPLASMA GONDII IGG (K902792)Pharmacia Diagnostics, Inc.1990-07-24
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO. (K900818)Vitek Systems, Inc.1990-04-30
TOXO IGG ELISA TEST (K900354)Gull Laboratories, Inc.1990-04-16
PLATELIA TOXO IGM KIT (K894948)Kallestad Diag, A Div. of Erbamont, Inc.1990-03-15
MODIFIED CAPTIA(R) TOXO-M (K900655)Mercia Diagnostics , Ltd.1990-03-06
DETECTADOT (TM) SYSTEM 2000 TOXO IGM TEST (K893200)Gull Laboratories, Inc.1989-12-18
TOXO ELISA TEST SYSTEM (K891781)Zeus Scientific, Inc.1989-07-14
IMX TOXO IGM ANTIBODY ASSAY (K890032)Abbott Laboratories1989-06-23
IMX TOXO IGG ANTIBODY ASSAY (K890031)Abbott Laboratories1989-06-23
IMMUNOCOMB(TM) TOXOPLASMA IGG ANTIBODY TEST KIT (K885344)Orgenics, Ltd.1989-04-12
MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT (K884249)Disease Detection International, Inc.1989-04-10
MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA (K890154)Labsystems, Inc.1989-02-07
ORTHO* TOXOPLASMA-G ANTIBODY ELISA TEST (K883937)Ortho Diagnostic Systems, Inc.1989-02-07
TREND(R) EMERGE(TM) TOXOPLASMA IGG ELISA (K883720)Lmd Laboratories1989-01-24
ORTHO* TOXOPLASMA-M ANTIBODY ELISA TEST (K883936)Ortho Diagnostic Systems, Inc.1988-10-06
TOXOPLASMA GONDII IGG ELISA KIT (K875258)De Ferris Laboratories, Inc.1988-09-30
CAPTIA TOXO-G (K880918)Mercia Diagnostics , Ltd.1988-08-01
SERODOT TOXOPLASMA IGG TEST KIT (K875363)Disease Detection International, Inc.1988-04-21
BIOTROL TOXO ELISA TEST G (K873294)Biotrol, USA, Inc.1988-04-12
BIOTROL TOXO ELISA TEST M (K873293)Biotrol, USA, Inc.1988-04-12
TOXOSTAT M TEST KIT (K875113)Whittaker Bioproducts, Inc.1988-04-12
TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560 (K874594)Clinical Sciences, Inc.1988-03-07
DETECTADOT SYSTEM 2000 TOXO IGG TEST (K875109)Gull Laboratories, Inc.1988-03-07
CHROMOTITRE E.I.A. TOXOPLASMA IGM (K872070)Ismunit Istituto Immunologico Intaliano1987-10-20
CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY (K871746)Mercia Diagnostics , Ltd.1987-07-31
TOXOPLASMA GONDII IGG ELISA (K871905)Electro-Nucleonics Laboratories, Inc.1987-07-30
MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT (K872252)Labsystems, Inc.1987-07-01
TOXOPLASMA IGM MICROASSAY (K870753)Diamedix Corp.1987-04-28
ACCUPOINT TOXO (K865068)Syva Co.1987-02-20
TOXOPLASMA IGG MICROASSAY (K863813)Diamedix Corp.1986-11-28
CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY (K863363)Cytotech, Inc.1986-11-13
TOXONOSTIKA IGM MICROELISA SYSTEM (K862196)Organon Teknika Corp.1986-09-11
ORGANON TEKNIKA TOXONOSTIKA IGG MICROELISA SYSTEM (K862189)Organon Teknika Corp.1986-09-08
TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT) (K862216)Labsystems, Inc.1986-06-30
MUREX SUDS TOXO (K861458)Murex Corp.1986-06-13
TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560 (K860773)Clinical Sciences, Inc.1986-05-23
ABBOTT TOXO-M EIA DIAGNOSTIC KIT (K850567)Abbott Laboratories1985-07-09
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