LSE · Class I · 21 CFR 866.3235

FDA Product Code LSE: Epstein-barr Virus, Other

Leading manufacturers include Zeus Scientific, Inc., DiaSorin, Inc. and Whittaker Bioproducts, Inc..

58
Total
58
Cleared
176d
Avg days
1988
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 249d recently vs 173d historically

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

58 devices
1–24 of 58
Cleared Oct 02, 2026
Elecsys EBV EBNA IgG
K260221
Roche Diagnostics
Microbiology · 249d
Cleared Oct 02, 2026
Elecsys EBV VCA IgG
K260232
Roche Diagnostics
Microbiology · 249d
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 Jul 28, 2008
PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G
K073382
Focus Diagnostics, Inc.
Microbiology · 238d
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 Jun 27, 2003
EBV VCA-P18 IGG ELISA
K030863
Panbio Limited
Microbiology · 101d
Cleared Sep 27, 2002
EBV EA-D IGG ELISA KIT, MODEL EBG-100
K021793
Pan Bio Pty. , Ltd.
Microbiology · 119d
Cleared Jun 11, 2001
IMMUNOWELL EA (D) IGG TEST
K010301
Genbio
Microbiology · 130d
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

About Product Code LSE - Regulatory Context

510(k) Submission Activity

58 total 510(k) submissions under product code LSE since 1988, with 58 receiving FDA clearance (average review time: 176 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - LSE Product Code

Recent submissions under LSE have taken an average of 249 days to reach a decision - up from 173 days historically. Manufacturers should account for longer review timelines in current project planning.

LSE devices are reviewed by the Microbiology panel. Browse all Microbiology devices →