LSE · Class I · 21 CFR 866.3235

FDA Product Code LSE: Epstein-barr Virus, Other

Leading manufacturers include DiaSorin, Inc., Zeus Scientific, Inc. and Quest Intl., 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 Jun 08, 2009
SERAQUEST EBV EA-D IGG TEST
K091260
Quest Intl., Inc.
Microbiology · 40d
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 Jan 16, 2004
MODIFICATION TO SERAQUEST EB VCA IGG
K033915
Quest Intl., Inc.
Microbiology · 29d
Cleared Dec 22, 1999
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM
K992587
Stellar Bio Systems, Inc.
Microbiology · 142d
Cleared Nov 02, 1999
SERAQUEST EB NA IGG
K991975
Quest Intl., Inc.
Microbiology · 144d
Cleared Oct 28, 1999
SERAQUEST EB VCA IGG
K990410
Quest Intl., Inc.
Microbiology · 261d
Cleared Jul 12, 1999
ETI-EA-G ASSAY
K992191
DiaSorin, Inc.
Microbiology · 14d
Cleared Jun 09, 1999
BIOTEST ANTI-EBV RECOMBINANT
K983839
Biotest Diagnostics Corp.
Microbiology · 222d
Cleared Jun 09, 1999
BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG
K983841
Biotest Diagnostics Corp.
Microbiology · 222d
Cleared Jun 09, 1999
BIOTEST ANTI-EBV RECOMBINANT, EA IGM
K983842
Biotest Diagnostics Corp.
Microbiology · 222d
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 Nov 25, 1998
EBNA-1 IGM ELISA TEST SYSTEM
K982348
Columbia Bioscience, Inc.
Microbiology · 142d
Cleared Nov 25, 1998
EA-D IGM ELISA TEST SYSTEM
K982350
Columbia Bioscience, Inc.
Microbiology · 142d
Cleared Nov 25, 1998
VCA IGM ELISA TEST SYSTEM
K982352
Columbia Bioscience, Inc.
Microbiology · 142d
Cleared Sep 22, 1998
IMMUNODOT MONO-G TEST
K974226
Genbio
Microbiology · 314d
Cleared Sep 22, 1998
IMMUNODOT MONO-M TEST
K974244
Genbio
Microbiology · 314d

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.