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LGD — Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Class II

FDA Device Classification

Classification Details

Product Code
LGD
Device Class
Class II
Regulation Number
866.3780
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242022beckman coulterAccess Toxo IgGMarch 28, 2025
K242095beckman coulterAccess Toxo IgM IIOctober 11, 2024
K233932abbott laboratoriesAlinity i Toxo IgMAugust 30, 2024
K210596abbott laboratoriesARCHITECT Toxo IgGMay 19, 2022
K162678roche diagnosticsElecsys Toxo IgM, Elecsys Toxo IgM PreciControlJune 23, 2017
K142826siemens healthcare diagnosticsADVIA Centaur Toxoplasma M (Toxo M)December 22, 2015
K132234diasorinLIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG IIAugust 28, 2013
K131441diasorinLIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM IIAugust 9, 2013
K101946biomerieuxVIDAS TOXO IGG AVIDITYMay 18, 2011
K102681siemens healthcare diagnosticsADVIA CENTAUR TOXOPLASMA IGG (TOXO G)May 4, 2011
K090847bio-rad laboratoriesPLATELIA TOXO IGM KIT MODEL 26211July 1, 2009
K073501roche diagnosticsROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGGJune 9, 2008
K080869beckman coulterACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QCMay 23, 2008
K052499diasorinDIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYSFebruary 8, 2006
K032162beckman coulterACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAYAugust 8, 2003
K031506beckman coulterACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAYJune 2, 2003
K013839bio-radBIO-RAD PLATELIA TOXO IGG TMBSeptember 30, 2002
K013837bio-radBIO-RAD PLATELIA TOXO IGM TMBSeptember 30, 2002
K012075diagnostic productsIMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MOJanuary 10, 2002
K012183bayer diagnosticsBAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAYDecember 27, 2001