ClearanceBrief
Panels › Microbiology › Product code LSE · Class 1

Epstein-Barr Virus, Other

Regulation 866.3235

2510(k)s in 12 months (58 all time)
1recalls in 12 months (7 all time)
5recalls that name a 510(k)
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Top companies in LSE

Company510(k)sRecalls
DiaSorin, Inc.51
Bio-Rad Laboratories, Inc.23
Zeus Scientific, Inc.50
Genbio40
Quest Intl., Inc.40
Whittaker Bioproducts, Inc.40
Biotest Diagnostics Corp.30
Clark Laboratories, Inc.30
Columbia Bioscience, Inc.30
Gull Laboratories, Inc.30
Decided510(k)Device and applicantCode
Oct 2, 2026K260232Elecsys EBV VCA IgG
Roche Diagnostics
LSE
Oct 2, 2026K260221Elecsys EBV EBNA IgG
Roche Diagnostics
LSE
Aug 7, 2024K233606ADVIA Centaur EBV-VCA IgM
Biokit, S.A., ES
LSE
Jan 5, 2017K162961LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set
DiaSorin, Inc.
LSE
Jan 4, 2017K162959LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set
DiaSorin, Inc.
LSE
Jun 8, 2009K091260SERAQUEST EBV EA-D IGG TEST
Quest Intl., Inc.
LSE
Jul 28, 2008K073382PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G
Focus Diagnostics, Inc.
LSE
Dec 8, 2006K062213BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
Bio-Rad Laboratories, Inc.
LSE
Dec 8, 2006K062211BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
Bio-Rad Laboratories, Inc.
LSE
Oct 18, 2006K060204LIAISON EA IGG
DiaSorin, Inc.
LSE
Jan 16, 2004K033915MODIFICATION TO SERAQUEST EB VCA IGG
Quest Intl., Inc.
LSE
Jun 27, 2003K030863EBV VCA-P18 IGG ELISA
Panbio Limited, AU
LSE
Sep 27, 2002K021793EBV EA-D IGG ELISA KIT, MODEL EBG-100
Pan Bio Pty. , Ltd., AU
LSE
Jun 11, 2001K010301IMMUNOWELL EA (D) IGG TEST
Genbio
LSE
Dec 22, 1999K992587EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM
Stellar Bio Systems, Inc.
LSE
Nov 2, 1999K991975SERAQUEST EB NA IGG
Quest Intl., Inc.
LSE
Oct 28, 1999K990410SERAQUEST EB VCA IGG
Quest Intl., Inc.
LSE
Jul 12, 1999K992191ETI-EA-G ASSAY
DiaSorin, Inc.
LSE
Jun 9, 1999K983842BIOTEST ANTI-EBV RECOMBINANT, EA IGM
Biotest Diagnostics Corp.
LSE
Jun 9, 1999K983841BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG
Biotest Diagnostics Corp.
LSE
Jun 9, 1999K983839BIOTEST ANTI-EBV RECOMBINANT
Biotest Diagnostics Corp.
LSE
Jun 4, 1999K991660COPALIS MULTIPLEX EBV ANTIBODY ASSAY
DiaSorin, Inc.
LSE
Mar 4, 1999K981812EBV-VCA IGG ELISA TEST SYSTEM
Diamedix Corp.
LSE
Dec 10, 1998K983801THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO
Zeus Scientific, Inc.
LSE
Dec 8, 1998K983804THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
Zeus Scientific, Inc.
LSE
Nov 25, 1998K982352VCA IGM ELISA TEST SYSTEM
Columbia Bioscience, Inc.
LSE
Nov 25, 1998K982350EA-D IGM ELISA TEST SYSTEM
Columbia Bioscience, Inc.
LSE
Nov 25, 1998K982348EBNA-1 IGM ELISA TEST SYSTEM
Columbia Bioscience, Inc.
LSE
Sep 22, 1998K974244IMMUNODOT MONO-M TEST
Genbio
LSE
Sep 22, 1998K974226IMMUNODOT MONO-G TEST
Genbio
LSE
Aug 21, 1998K981120ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA
Zeus Scientific, Inc.
LSE
Aug 10, 1998K973940IMMUNOWELL EBV VCA IGG TEST
Genbio
LSE
Jul 22, 1998K980912VCA IGG ELISA TEST SYSTEM
Clark Laboratories, Inc.
LSE
Jul 22, 1998K980596VCA IGM ELISA TEST SYSTEM
Clark Laboratories, Inc.
LSE
Mar 26, 1998K973123EA-D IGG ELISA TEST SYSTEM
Clark Laboratories, Inc.
LSE
Sep 25, 1995K944449EBV-VCA IGM ELISA TEST STSTEM
Zeus Scientific, Inc.
LSE
Sep 15, 1995K940093EBV-EA(D) IGG ELISA TEST
Gull Laboratories, Inc.
LSE
Aug 23, 1995K941198EBV LGG ELISA TEST
Gull Laboratories, Inc.
LSE
Jun 7, 1995K946159INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KIT
Incstar Corp.
LSE
Jun 7, 1995K946157INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT
Incstar Corp.
LSE
Apr 20, 1994K934774UNKNOWN
Granbio, Inc.
LSE
Nov 5, 1993K931443ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS
Ortho Diagnostic Systems, Inc.
LSE
Oct 12, 1993K925688MERIDIAN EBV-EA TEST KIT
Fuller Laboratories, Inc.
LSE
Sep 14, 1992K921628EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA
Incstar Corp.
LSE
Sep 2, 1992K922332BARTELS EPSTEIN-BARR VIRUS IGG EIA
Baxter Diagnostics, Inc.
LSE
Jul 24, 1991K912489COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS
Immuno Concepts, Inc.
LSE
Jul 24, 1991K912488FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS
Immuno Concepts, Inc.
LSE
Oct 16, 1990K903612EBV/EA-CHECK TM TEST KIT
Diagnostic Technology, Inc.
LSE
Dec 18, 1989K895652EBV-EA IFA KIT
Organon Teknika Treyburn
LSE
Oct 16, 1989K894932FIAX EB VCA-M TEST KIT
Whittaker Bioproducts, Inc.
LSE

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