Home / Device Classification / LSE

LSE — Epstein-Barr Virus, Other Class I

FDA Device Classification

Classification Details

Product Code
LSE
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
K233606biokitADVIA Centaur EBV-VCA IgMAugust 7, 2024
K162961diasorinLIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LJanuary 5, 2017
K162959diasorinLIAISON® EA IgG and LIAISON® EA IgG Serum Control SetJanuary 4, 2017
K091260quest intlSERAQUEST EBV EA-D IGG TESTJune 8, 2009
K073382focus diagnosticsPLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500GJuly 28, 2008
K062213bio-rad laboratoriesBIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMDecember 8, 2006
K062211bio-rad laboratoriesBIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMDecember 8, 2006
K060204diasorinLIAISON EA IGGOctober 18, 2006
K033915quest intlMODIFICATION TO SERAQUEST EB VCA IGGJanuary 16, 2004
K030863panbio limitedEBV VCA-P18 IGG ELISAJune 27, 2003
K021793pan bio pty.EBV EA-D IGG ELISA KIT, MODEL EBG-100September 27, 2002
K010301genbioIMMUNOWELL EA (D) IGG TESTJune 11, 2001
K992587stellar bio systemsEPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEMDecember 22, 1999
K991975quest intlSERAQUEST EB NA IGGNovember 2, 1999
K990410quest intlSERAQUEST EB VCA IGGOctober 28, 1999
K992191diasorinETI-EA-G ASSAYJuly 12, 1999
K983841biotest diagnosticsBIOTEST ANTI-EBV RECOMBINANT, EBNA IGGJune 9, 1999
K983842biotest diagnosticsBIOTEST ANTI-EBV RECOMBINANT, EA IGMJune 9, 1999
K983839biotest diagnosticsBIOTEST ANTI-EBV RECOMBINANTJune 9, 1999
K991660diasorinCOPALIS MULTIPLEX EBV ANTIBODY ASSAYJune 4, 1999