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LJN — Antibody Igm, If, Epstein-Barr Virus Class I

FDA Device Classification

Classification Details

Product Code
LJN
Device Class
Class I
Regulation Number
866.3235
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K123021bio-rad laboratoriesBIOPLEX 2200 EBV IGM KITNovember 2, 2012
K073381focus diagnosticsPLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600MAugust 4, 2008
K042092zeus scientificATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEMApril 12, 2005
K033780quest intlMODIFICATION TO SERAQUEST VCA IGMJanuary 15, 2004
K990977quest intlSERAQUEST EB VAC IGMOctober 6, 1999
K991459diasorinCOPALIS EBV-M ANTIBODY ASSAYMay 14, 1999
K973939genbioIMMUNOWELL VCA IGM TESTAugust 10, 1998
K931520mrl diagnosticsEPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODYApril 26, 1994
K930020ortho diagnostic systemsORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISAJuly 16, 1993
K922331baxter diagnosticsBARTELS EPSTEIN-BARR VIRUS IGM EIASeptember 2, 1992
K915348pharmacia diagnosticsEBV-VCA IGM ELISAFebruary 14, 1992
K911362amico laboratoriesAMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TESTOctober 7, 1991
K910042gull laboratoriesEBV IGM ELISA TESTFebruary 21, 1991
K901840granbio(EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUMSeptember 12, 1990
K896594hillcrest biologicalsEBV VCA ANTIBODY (IGM)January 16, 1990
K893240bion entBION EBV-M (VCA) TEST SYSTEMJuly 14, 1989
K890639diagnostic technologyRESUBMITTED EBV/IGM-CHECK TEST KITJune 20, 1989
K880884immuno conceptsEBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME)August 30, 1988
K880886immuno conceptsEBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT)August 30, 1988
K875204e.i. dupont de nemours and coDU PONT VCA-IGM ANTIBODY ELISA KITJuly 8, 1988