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LOL — Hepatitis A Test (Antibody And Igm Antibody) Class II

FDA Device Classification

Classification Details

Product Code
LOL
Device Class
Class II
Regulation Number
866.3310
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251995beckman coulterAccess anti-HAV IgMJanuary 27, 2026
K243846beckman coulterAccess anti-HAVSeptember 9, 2025
K222850abbott laboratoriesHAVAb IgG IIAugust 10, 2023
K223403diasorinLIAISON Anti-HAV; LIAISON XSDecember 9, 2022
K210272diasorinLIAISON Anti-HAVFebruary 9, 2021
K193532diasorinLIAISON Anti-HAV AssayMarch 2, 2020
K190428roche diagnosticsElecsys Anti-HAV IIAugust 13, 2019
K161964siemens healthcare diagnosticsADVIA Centaur HAV IgM AssayOctober 13, 2016
K160650diasorinLIAISON HAV IgM, LIAISON Control HAV IgMAugust 25, 2016
K142758siemens healthcare diagnosticsADVIA Centaur HAV total assayDecember 5, 2014
K141116diasorinLIAISON XL ANALYZERJuly 25, 2014
K113704abbott laboratoriesARCHITECT HAVAB-GJune 28, 2012
K103529diasorinLIAISON XL ANALYZER MODEL 10050January 21, 2011
K100903roche professional diagnosticsANTI-HAVOctober 5, 2010
K093955roche diagnosticsANTI-HAV IGMJune 22, 2010
K092353bio-rad laboratoriesMONOLISA ANTI-HAV IGM EIAOctober 29, 2009
K092355bio-rad laboratoriesMONOLISA ANTI-HAV EIAOctober 29, 2009
K082049diasorinLIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAVDecember 5, 2008
K082050diasorinLIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGMNovember 3, 2008
K081716siemens healthcare diagnosticsADVIA CENTAUR HAVM ASSAYJuly 17, 2008