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
K210596 Abbott Laboratories ARCHITECT Toxo IgG 05/19/2022
K954575 ABBOTT LABORATORIES AXSYM TOXO IGG ANTIBODY ASSAY 08/16/1996
K954576 ABBOTT LABORATORIES AXSYM TOXO IGM 08/23/1996
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
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
K944867 BIO-WHITTAKER, INC., A CAMBREX CO. TOXOSTAT 05/14/1996
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
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
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
K962343 GULL LABORATORIES, INC. TOXO IGG ELISA TEST 03/24/1997
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
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
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
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


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