FDA.reportPublic FDA data

510(k) K233606

Device
ADVIA Centaur EBV-VCA IgM
Applicant
Biokit, S.A.
510(k) number
K233606
Product code
LSE
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-07
Date received
2023-11-09
Regulation
866.3235
Classification name
Epstein-Barr Virus, Other
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Dominique Monferrer
Address
Av. Can Montcau, 7 Lliçà D’Amunt, Barcelona ES 08186 08186

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LSE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K162961LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control SetDiaSorin, Inc.2017-01-05
K162959LIAISON® EA IgG and LIAISON® EA IgG Serum Control SetDiaSorin, Inc.2017-01-04
K091260SERAQUEST EBV EA-D IGG TESTQuest Intl., Inc.2009-06-08
K073382PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500GFocus Diagnostics, Inc.2008-07-28
K062211BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMBio-Rad Laboratories, Inc.2006-12-08
K062213BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMBio-Rad Laboratories, Inc.2006-12-08
K060204LIAISON EA IGGDiaSorin, Inc.2006-10-18
K033915MODIFICATION TO SERAQUEST EB VCA IGGQuest Intl., Inc.2004-01-16
K030863EBV VCA-P18 IGG ELISAPanbio Limited2003-06-27
K021793EBV EA-D IGG ELISA KIT, MODEL EBG-100Pan Bio Pty. , Ltd.2002-09-27
K010301IMMUNOWELL EA (D) IGG TESTGenbio2001-06-11
K992587EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEMStellar Bio Systems, Inc.1999-12-22
K991975SERAQUEST EB NA IGGQuest Intl., Inc.1999-11-02
K990410SERAQUEST EB VCA IGGQuest Intl., Inc.1999-10-28
K992191ETI-EA-G ASSAYDiaSorin, Inc.1999-07-12