FDA 510(k) Applications for Medical Device Product Code "LGD"
(Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii)

FDA 510(k) Number Applicant Device Name Decision Date
K913106 ABBOTT LABORATORIES ABBOTT IMX TOXO IGM POSITIVE CONTROL 11/29/1991
K850567 ABBOTT LABORATORIES ABBOTT TOXO-M EIA DIAGNOSTIC KIT 07/09/1985
K910416 ABBOTT LABORATORIES ABBOTT TOXO-M EIA HIGH POSITIVE CONTROL 02/26/1991
K954575 ABBOTT LABORATORIES AXSYM TOXO IGG ANTIBODY ASSAY 08/16/1996
K954576 ABBOTT LABORATORIES AXSYM TOXO IGM 08/23/1996
K951636 ABBOTT LABORATORIES IMX TOXO IGG 08/01/1995
K890031 ABBOTT LABORATORIES IMX TOXO IGG ANTIBODY ASSAY 06/23/1989
K890032 ABBOTT LABORATORIES IMX TOXO IGM ANTIBODY ASSAY 06/23/1989
K945634 ABBOTT LABORATORIES IMX(R) TOXO IGM 04/27/1995
K840879 ABBOTT LABORATORIES TOXO-G EIA DIAGNOSTIC KIT 05/21/1984
K842528 AMICO LAB, INC. AMIZYME-TOXOPLASMA GONDII KIT 09/07/1984
K922585 BAXTER DIAGNOSTICS, INC. BARTELS TOXOPLASMA IGG EIA 09/02/1992
K922579 BAXTER DIAGNOSTICS, INC. BARTELS TOXOPLASMA IGM EIA 09/02/1992
K010755 BAYER CORP. BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY 08/20/2001
K955760 BAYER CORP. TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM 08/02/1996
K971989 BAYER CORP. TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) 10/22/1997
K012183 BAYER DIAGNOSTICS CORP. BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY 12/27/2001
K032162 BECKMAN COULTER, INC. ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY 08/08/2003
K031506 BECKMAN COULTER, INC. ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY 06/02/2003
K080869 BECKMAN COULTER, INC. ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC 05/23/2008
K003259 BECKMAN COULTER, INC. ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479 06/13/2001
K002453 BECKMAN COULTER, INC. ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479 08/31/2000
K973448 BECKMAN INSTRUMENTS, INC. ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469 09/17/1998
K913505 BEHRING DIAGNOSTICS, INC. ENZYGNOST TOXOPLASMOSIS/IGM 03/04/1992
K913731 BEHRING DIAGNOSTICS, INC. ENZYGNOST(R) TOXOPLASMOSIS/IGG 04/29/1992
K013839 BIO-RAD BIO-RAD PLATELIA TOXO IGG TMB 09/30/2002
K013837 BIO-RAD BIO-RAD PLATELIA TOXO IGM TMB 09/30/2002
K090847 Bio-Rad Laboratories PLATELIA TOXO IGM KIT MODEL 26211 07/01/2009
K951495 BIO-RAD LABORATORIES, INC. ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM 12/20/1995
K944867 BIO-WHITTAKER, INC., A CAMBREX CO. TOXOSTAT 05/14/1996
K931334 BIOMERIEUX VITEK, INC. VIDAS TOXO COMPETITION (TXC) ASSAY 06/21/1993
K922737 BIOMERIEUX VITEK, INC. VIDAS TOXO IG6 ASSAY (TX6) 05/11/1993
K923166 BIOMERIEUX VITEK, INC. VIDAS TOXOPLASMA GONDII IGM ASSSAY 02/25/1993
K101946 BIOMERIEUX, INC. VIDAS TOXO IGG AVIDITY 05/18/2011
K993319 BIOMERIEUX, INC. VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 05/22/2000
K873294 BIOTROL, USA, INC. BIOTROL TOXO ELISA TEST G 04/12/1988
K873293 BIOTROL, USA, INC. BIOTROL TOXO ELISA TEST M 04/12/1988
K860773 CLINICAL SCIENCES, INC. TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560 05/23/1986
K874594 CLINICAL SCIENCES, INC. TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560 03/07/1988
K843417 CORDIS CORP. CORDIA T-M 01/04/1985
K863363 CYTOTECH, INC. CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY 11/13/1986
K875258 DE FERRIS LABORATORIES, INC. TOXOPLASMA GONDII IGG ELISA KIT 09/30/1988
K950671 DIAGNOSTIC PRODUCTS CORP. IMMULITE TOXOPLASMA GONDII IGG 02/23/1996
K012075 DIAGNOSTIC PRODUCTS CORP. IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6 01/10/2002
K962936 DIAGNOSTIC PRODUCTS CORP. IMMULITE TOXOPLASMA QUANTITATIVE IGG 04/24/1997
K001707 DIAMEDIX CORP. DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM 07/07/2000
K981498 DIAMEDIX CORP. IS-TOXOPLASMA IGG TEST SYSTEM 08/21/1998
K863813 DIAMEDIX CORP. TOXOPLASMA IGG MICROASSAY 11/28/1986
K870753 DIAMEDIX CORP. TOXOPLASMA IGM MICROASSAY 04/28/1987
K052499 DIASORIN S.P.A. DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS 02/08/2006
K131441 DIASORIN, INC. LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II 08/09/2013
K132234 DIASORIN, INC. LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II 08/28/2013
K903968 DIFCO LABORATORIES, INC. TOXO-CUBE 12/18/1990
K884249 DISEASE DETECTION INTERNATIONAL, INC. MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT 04/10/1989
K875363 DISEASE DETECTION INTERNATIONAL, INC. SERODOT TOXOPLASMA IGG TEST KIT 04/21/1988
K871905 ELECTRO-NUCLEONICS LABORATORIES, INC. TOXOPLASMA GONDII IGG ELISA 07/30/1987
K893200 GULL LABORATORIES, INC. DETECTADOT (TM) SYSTEM 2000 TOXO IGM TEST 12/18/1989
K875109 GULL LABORATORIES, INC. DETECTADOT SYSTEM 2000 TOXO IGG TEST 03/07/1988
K900354 GULL LABORATORIES, INC. TOXO IGG ELISA TEST 04/16/1990
K962343 GULL LABORATORIES, INC. TOXO IGG ELISA TEST 03/24/1997
K915891 GULL LABORATORIES, INC. TOXO IGG ELISA TEST (MODIFIED) 03/04/1992
K903324 GULL LABORATORIES, INC. TOXO IGM ELISA TEST 10/16/1990
K963296 INCSTAR CORP. INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565) 12/16/1996
K963297 INCSTAR CORP. INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560) 12/16/1996
K963289 INCSTAR CORP. INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY 05/01/1997
K971441 INOVA DIAGNOSTICS, INC. QUANTA LITE TOXOPLASMA IGG 12/02/1997
K872070 ISMUNIT ISTITUTO IMMUNOLOGICO INTALIANO CHROMOTITRE E.I.A. TOXOPLASMA IGM 10/20/1987
K894948 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. PLATELIA TOXO IGM KIT 03/15/1990
K890154 LABSYSTEMS, INC. MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA 02/07/1989
K872252 LABSYSTEMS, INC. MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT 07/01/1987
K833829 LABSYSTEMS, INC. TOXOPLASMA GOND II IGG DIA TEST KIT 04/24/1984
K862216 LABSYSTEMS, INC. TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT) 06/30/1986
K842797 LABSYSTEMS, INC. TOXOPLASMA GONDII IGM EIA TEST KIT 10/17/1984
K883720 LMD LABORATORIES TREND(R) EMERGE(TM) TOXOPLASMA IGG ELISA 01/24/1989
K813221 M.A. BIOPRODUCTS TOXOELISA TEST KIT 01/26/1982
K880918 MERCIA DIAGNOSTICS LTD. CAPTIA TOXO-G 08/01/1988
K871746 MERCIA DIAGNOSTICS LTD. CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY 07/31/1987
K900655 MERCIA DIAGNOSTICS LTD. MODIFIED CAPTIA(R) TOXO-M 03/06/1990
K861458 MUREX CORP. MUREX SUDS TOXO 06/13/1986
K862189 ORGANON TEKNIKA CORP. ORGANON TEKNIKA TOXONOSTIKA IGG MICROELISA SYSTEM 09/08/1986
K862196 ORGANON TEKNIKA CORP. TOXONOSTIKA IGM MICROELISA SYSTEM 09/11/1986
K885344 ORGENICS LTD. IMMUNOCOMB(TM) TOXOPLASMA IGG ANTIBODY TEST KIT 04/12/1989
K883937 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHO* TOXOPLASMA-G ANTIBODY ELISA TEST 02/07/1989
K883936 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHO* TOXOPLASMA-M ANTIBODY ELISA TEST 10/06/1988
K911834 PB DIAGNOSTIC SYSTEMS, INC. OPUS(R) ROZO 08/12/1991
K921523 PB DIAGNOSTICS, INC. OPUS(R) TOXO-G TEST SYSTEM 09/14/1992
K920702 PHARMACIA DIAGNOSTICS, INC. TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO 07/08/1992
K902792 PHARMACIA DIAGNOSTICS, INC. TOXOPLASMA GONDII IGG 07/24/1990
K960092 QUEST INTL., INC. SERAQUEST TOXOPLASMA IGG 06/17/1996
K971672 QUEST INTL., INC. SERAQUEST TOXOPLASMA IGM 10/21/1997
K162678 ROCHE DIAGNOSTICS Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl 06/23/2017
K073501 ROCHE DIAGNOSTICS CORP. ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG 06/09/2008
K914852 SCLAVO, INC. ELISA TOXO IGM 01/23/1992
K102681 Siemens Healthcare Diagnostics Inc. ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) 05/04/2011
K142826 SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA Centaur Toxoplasma M (Toxo M) 12/22/2015
K865068 SYVA CO. ACCUPOINT TOXO 02/20/1987
K900818 VITEK SYSTEMS, INC. VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO. 04/30/1990
K875113 WHITTAKER BIOPRODUCTS, INC. TOXOSTAT M TEST KIT 04/12/1988
K984317 ZEUS SCIENTIFIC, INC. THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)F 01/22/1999
K984170 ZEUS SCIENTIFIC, INC. THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGM ELISA TEST SYSTEM 01/19/1999
K891781 ZEUS SCIENTIFIC, INC. TOXO ELISA TEST SYSTEM 07/14/1989
K913787 ZEUS SCIENTIFIC, INC. TOXOPLASMA IGM ELISA TEST SYSTEM 12/18/1991


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