FDA.reportPublic FDA data

510(k) K233605

Device
ADVIA Centaur EBV-EBNA IgG
Applicant
Biokit, S.A.
510(k) number
K233605
Product code
LLM
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-07
Date received
2023-11-09
Regulation
866.3235
Classification name
Test, Antigen, Nuclear, Epstein-Barr Virus
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 LLM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K040120DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYSDiaSorin, Inc.2005-04-29
K984133THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THZeus Scientific, Inc.1999-01-11
K973941IMMUNOWELL EBNA IGG TESTGenbio1998-08-10
K980598EBNA-1 IGM ELISA TEST SYSTEMClark Laboratories, Inc.1998-05-01
K951549EBNA IGG EIA TEST SYSTEMImmunoprobe, Inc.1996-04-29
K951822EBNA ENZYME IMMUNOASSAY KITGranbio, Inc.1996-02-15
K935730EBNA IGG ELISA TESTGull Laboratories, Inc.1995-09-19
K946353EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAYMrl Diagnostics1995-07-21
K946158INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KITIncstar Corp.1995-06-09
K932742EBNA IGG ELISA TEST SYSTEMZeus Scientific, Inc.1995-05-05
K925690MERIDIAN EBNA TEST KITFuller Laboratories, Inc.1993-10-12
K930002ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISAOrtho Diagnostic Systems, Inc.1993-07-16
K911473EBNA STAT TEST KITWhittaker Bioproducts, Inc.1991-09-25
K911569EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TESTOrtho Diagnostic Systems, Inc.1991-06-10
K895708EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI)Immuno Concepts, Inc.1989-12-11