LSE · Class I · 21 CFR 866.3235

FDA Product Code LSE: Epstein-barr Virus, Other

Leading manufacturers include DiaSorin, Inc., Zeus Scientific, Inc. and Gull Laboratories, Inc..

56
Total
56
Cleared
173d
Avg days
1988
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Epstein-barr Virus, Other Devices (Product Code LSE)

56 devices
1–24 of 56
Cleared Aug 07, 2024
ADVIA Centaur EBV-VCA IgM
K233606
Biokit, S.A.
Microbiology · 272d
Cleared Jan 05, 2017
LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set
K162961
DiaSorin, Inc.
Microbiology · 73d
Cleared Jan 04, 2017
LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set
K162959
DiaSorin, Inc.
Microbiology · 72d
Cleared Dec 08, 2006
BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K062211
Bio-Rad Laboratories, Inc.
Microbiology · 129d
Cleared Dec 08, 2006
BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K062213
Bio-Rad Laboratories, Inc.
Microbiology · 129d
Cleared Oct 18, 2006
LIAISON EA IGG
K060204
DiaSorin, Inc.
Microbiology · 265d
Cleared Jul 12, 1999
ETI-EA-G ASSAY
K992191
DiaSorin, Inc.
Microbiology · 14d
Cleared Jun 04, 1999
COPALIS MULTIPLEX EBV ANTIBODY ASSAY
K991660
DiaSorin, Inc.
Microbiology · 21d
Cleared Mar 04, 1999
EBV-VCA IGG ELISA TEST SYSTEM
K981812
Diamedix Corp.
Microbiology · 286d
Cleared Dec 10, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO
K983801
Zeus Scientific, Inc.
Microbiology · 43d
Cleared Dec 08, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
K983804
Zeus Scientific, Inc.
Microbiology · 41d
Cleared Aug 21, 1998
ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA
K981120
Zeus Scientific, Inc.
Microbiology · 147d
Cleared Sep 25, 1995
EBV-VCA IGM ELISA TEST STSTEM
K944449
Zeus Scientific, Inc.
Microbiology · 378d
Cleared Sep 15, 1995
EBV-EA(D) IGG ELISA TEST
K940093
Gull Laboratories, Inc.
Microbiology · 616d
Cleared Aug 23, 1995
EBV LGG ELISA TEST
K941198
Gull Laboratories, Inc.
Microbiology · 527d
Cleared Jun 07, 1995
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT
K946157
Incstar Corp.
Microbiology · 181d
Cleared Jun 07, 1995
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KIT
K946159
Incstar Corp.
Microbiology · 181d
Cleared Nov 05, 1993
ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS
K931443
Ortho Diagnostic Systems, Inc.
Microbiology · 228d
Cleared Sep 14, 1992
EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA
K921628
Incstar Corp.
Microbiology · 161d
Cleared Sep 02, 1992
BARTELS EPSTEIN-BARR VIRUS IGG EIA
K922332
Baxter Diagnostics, Inc.
Microbiology · 112d
Cleared Jul 24, 1991
FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS
K912488
Immuno Concepts, Inc.
Microbiology · 50d
Cleared Jul 24, 1991
COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS
K912489
Immuno Concepts, Inc.
Microbiology · 50d
Cleared Dec 15, 1988
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TES
K882447
Zeus Scientific, Inc.
Microbiology · 184d
Cleared Jan 05, 1988
EBV-EA TEST
K872617
Gull Laboratories, Inc.
Microbiology · 183d

About Product Code LSE - Regulatory Context

510(k) Submission Activity

56 total 510(k) submissions under product code LSE since 1988, with 56 receiving FDA clearance (average review time: 173 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.