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LFZ — Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus Class II

FDA Device Classification

Classification Details

Product Code
LFZ
Device Class
Class II
Regulation Number
866.3175
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K220949abbott laboratoriesArchitect CMV IgGOctober 27, 2022
K220911roche diagnosticsElecsys CMV IgGOctober 12, 2022
K181213siemens healthcare diagnosticsADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality ControlJuly 30, 2018
K163569roche diagnosticsElecsys CMV IgMMarch 17, 2017
K162969diasorinLIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetJanuary 6, 2017
K142133roche diagnosticsELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGMOctober 24, 2014
K131605roche diagnosticsELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAYFebruary 28, 2014
K040290diasorinDIASORIN LIAISON CMV IGM/IGGJune 1, 2005
K993952diagnostic productsIMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6December 16, 1999
K982485quest intlSERAQUEST CMV IGMJanuary 13, 1999
K984139zeus scientificTHE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LIJanuary 11, 1999
K983803zeus scientificTHE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LIDecember 14, 1998
K982027diasorinMODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAYNovember 25, 1998
K981163diamedixDIAMEDIX IS-CMV IGG TEST SYSTEMSeptember 21, 1998
K971335inova diagnosticsQUANTA LITE CMV IGG ELISADecember 1, 1997
K954301abbott laboratoriesABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)March 24, 1997
K944438hemagen diagnosticsHEMAGEN CMV IGG KITFebruary 20, 1997
K960434incstarINCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530October 17, 1996
K963084behring diagnosticsOPUS CMV TEST SYSTEM-MODIFICATIONOctober 9, 1996
K953943abbott laboratoriesAXSYM CMV IGG ANTIBODY ASSAYSeptember 20, 1996