Home / Device Classification / LFY

LFY — Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster Class II

FDA Device Classification

Classification Details

Product Code
LFY
Device Class
Class II
Regulation Number
866.3900
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K231214diasorinLIAISON VZV IgG HT, LIAISON Control VZV IgG HTOctober 27, 2023
K150375diasorinLIAISON VZV IgG, LIAISON Control VZV IgGMarch 11, 2015
K070317zeus scientificZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEMJuly 5, 2007
K061820diasorinDIASORIN LIAISON VZV IGGFebruary 26, 2007
K051484zeus scientificZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.December 5, 2005
K984181zeus scientificTHE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEMJanuary 22, 1999
K981867diamedixIS-VZU IGG TEST SYSTEMSeptember 28, 1998
K972295quest intlSERAQUEST VZV IGGNovember 5, 1997
K961012zeus scientificVZV IGG ELISA TEST SYSTEMJuly 24, 1996
K943843biowhittaker molecular applicationsVARICELISA, MODIFICATIONMarch 14, 1996
K941046gull laboratoriesVZV IGG ELISA TESTAugust 24, 1995
K923122biomerieux vitekVITEK IMMUNODIAGNOSTIC ASSAY SYSTEMOctober 26, 1992
K914022pharmacia diagnosticsSERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUSJanuary 27, 1992
K900688clinical sciencesVARICELLA ZOSTER IGG CLIN-ELISA TEST KITMay 15, 1990
K890642diamedixVZV MICROASSAYMay 15, 1989
K833637bionetic laboratory productsVZV BIO-ENZABEAD SCREEN KITFebruary 10, 1984
K823805m.a. bioproductsVARICELISA TEST KITMay 5, 1983