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LFX — Enzyme Linked Immunoabsorbent Assay, Rubella Class II

FDA Device Classification

Classification Details

Product Code
LFX
Device Class
Class II
Regulation Number
866.3510
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250588beckman coulterAccess Rubella IgGNovember 17, 2025
K243168abbott laboratoriesAlinity i Rubella IgGJune 20, 2025
K122397diasorinLIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGMSeptember 6, 2012
K093101diamedixMAGO 4SJanuary 21, 2011
K092587bio-rad laboratoriesBIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SDecember 3, 2010
K092322roche diagnosticsELECSYS RUBELLA IGM IMMUNOASSAYMarch 12, 2010
K080766biomerieuxVIDAS RUB IGGDecember 23, 2008
K072617roche diagnosticsELECSYS RUBELLA IGG IMMUNOASSAYDecember 5, 2008
K073390diasorinDIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLSNovember 21, 2008
K063186zeus scientificATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEMMarch 21, 2007
K063143ortho-clinical diagnosticsVITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORSDecember 26, 2006
K031606beckman coulterACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAYJune 20, 2003
K012077diagnostic productsIMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRJanuary 10, 2002
K010668bayerBAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAYJuly 5, 2001
K003412bayerADVIA CENTAUR RUBELLA IGG ASSAYApril 13, 2001
K001875diamedixDIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEMAugust 21, 2000
K993291diasorinCOPALIS RUBELLA IGMFebruary 10, 2000
K984180zeus scientificTHE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEMJuly 20, 1999
K983805zeus scientificTHE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYMMay 26, 1999
K981729diamedixIS-RUBELLA IGG TEST SYSTEMJanuary 28, 1999