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LSE — Epstein-Barr Virus, Other Class I

FDA Device Classification

FDA product code LSE covers "Epstein-Barr Virus, Other", a Class I medical device regulated under 21 CFR 866.3235. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.

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 IgMAug 7, 2024
K162961DiasorinLIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LJan 5, 2017
K162959DiasorinLIAISON® EA IgG and LIAISON® EA IgG Serum Control SetJan 4, 2017
K091260Quest IntlSERAQUEST EBV EA-D IGG TESTJun 8, 2009
K073382Focus DiagnosticsPLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500GJul 28, 2008
K062213Bio-Rad LaboratoriesBIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMDec 8, 2006
K062211Bio-Rad LaboratoriesBIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMDec 8, 2006
K060204DiasorinLIAISON EA IGGOct 18, 2006
K033915Quest IntlMODIFICATION TO SERAQUEST EB VCA IGGJan 16, 2004
K030863Panbio LimitedEBV VCA-P18 IGG ELISAJun 27, 2003
K021793Pan Bio Pty.EBV EA-D IGG ELISA KIT, MODEL EBG-100Sep 27, 2002
K010301GenbioIMMUNOWELL EA (D) IGG TESTJun 11, 2001
K992587Stellar Bio SystemsEPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEMDec 22, 1999
K991975Quest IntlSERAQUEST EB NA IGGNov 2, 1999
K990410Quest IntlSERAQUEST EB VCA IGGOct 28, 1999
K992191DiasorinETI-EA-G ASSAYJul 12, 1999
K983839Biotest DiagnosticsBIOTEST ANTI-EBV RECOMBINANTJun 9, 1999
K983842Biotest DiagnosticsBIOTEST ANTI-EBV RECOMBINANT, EA IGMJun 9, 1999
K983841Biotest DiagnosticsBIOTEST ANTI-EBV RECOMBINANT, EBNA IGGJun 9, 1999
K991660DiasorinCOPALIS MULTIPLEX EBV ANTIBODY ASSAYJun 4, 1999

FDA data resources