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LLM — Test, Antigen, Nuclear, Epstein-Barr Virus Class I

FDA Device Classification

Classification Details

Product Code
LLM
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
K233605biokitADVIA Centaur EBV-EBNA IgGAugust 7, 2024
K040120diasorinDIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYSApril 29, 2005
K984133zeus scientificTHE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LJanuary 11, 1999
K973941genbioIMMUNOWELL EBNA IGG TESTAugust 10, 1998
K980598clark laboratoriesEBNA-1 IGM ELISA TEST SYSTEMMay 1, 1998
K951549immunoprobeEBNA IGG EIA TEST SYSTEMApril 29, 1996
K951822granbioEBNA ENZYME IMMUNOASSAY KITFebruary 15, 1996
K935730gull laboratoriesEBNA IGG ELISA TESTSeptember 19, 1995
K946353mrl diagnosticsEPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAYJuly 21, 1995
K946158incstarINCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KITJune 9, 1995
K932742zeus scientificEBNA IGG ELISA TEST SYSTEMMay 5, 1995
K925690fuller laboratoriesMERIDIAN EBNA TEST KITOctober 12, 1993
K930002ortho diagnostic systemsORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISAJuly 16, 1993
K911473whittaker bioproductsEBNA STAT TEST KITSeptember 25, 1991
K911569ortho diagnostic systemsEPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TESTJune 10, 1991
K895708immuno conceptsEBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI)December 11, 1989
K895707immuno conceptsEBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY)December 8, 1989
K894626bion entEPSTEIN-BARR VIRUS-NUCLEAR ANTIGENOctober 16, 1989
K891542diagnostic technologyEBNA-CHECK(TM) TEST KITJune 20, 1989
K883601clinical sciencesEPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550May 11, 1989