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 |