Product code LSE— Microbiology
VCA IGM ELISA TEST SYSTEM
- Classification name
- Epstein-Barr Virus, Other
- Device class
- Class 1
- Regulation
- 21 CFR 866.3235
- Advisory panel
- Microbiology
- Total cleared
- 58
- First cleared
- Most recent
Market context for product code LSE
FDA has cleared devices under product code LSE between 1988 and 2026, filed by 26 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 2026
- 2024
- 2017
- 2009
- 2008
- 2006
- 2004
- 2003
- 2002
- 2001
- 1999
- 1998
- 1995
- 1994
- 1993
Top applicants under product code LSE
Recent clearances under product code LSE
- K260221 — Elecsys EBV EBNA IgG
- K260232 — Elecsys EBV VCA IgG
- K233606 — ADVIA Centaur EBV-VCA IgM
- K162961 — LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set
- K162959 — LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set
- K091260 — SERAQUEST EBV EA-D IGG TEST
- K073382 — PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G
- K062211 — BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
- K062213 — BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
- K060204 — LIAISON EA IGG
- K033915 — MODIFICATION TO SERAQUEST EB VCA IGG
- K030863 — EBV VCA-P18 IGG ELISA
- K021793 — EBV EA-D IGG ELISA KIT, MODEL EBG-100
- K010301 — IMMUNOWELL EA (D) IGG TEST
- K992587 — EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM
- K991975 — SERAQUEST EB NA IGG
- K990410 — SERAQUEST EB VCA IGG
- K992191 — ETI-EA-G ASSAY
- K983839 — BIOTEST ANTI-EBV RECOMBINANT
- K983841 — BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG
- K983842 — BIOTEST ANTI-EBV RECOMBINANT, EA IGM
- K991660 — COPALIS MULTIPLEX EBV ANTIBODY ASSAY
- K981812 — EBV-VCA IGG ELISA TEST SYSTEM
- K983801 — THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO
- K983804 — THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
- K982348 — EBNA-1 IGM ELISA TEST SYSTEM
- K982350 — EA-D IGM ELISA TEST SYSTEM
- K982352 — VCA IGM ELISA TEST SYSTEM
- K974226 — IMMUNODOT MONO-G TEST
- K974244 — IMMUNODOT MONO-M TEST
- K981120 — ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA
- K973940 — IMMUNOWELL EBV VCA IGG TEST
- K980596 — VCA IGM ELISA TEST SYSTEM
- K980912 — VCA IGG ELISA TEST SYSTEM
- K973123 — EA-D IGG ELISA TEST SYSTEM
- K944449 — EBV-VCA IGM ELISA TEST STSTEM
- K940093 — EBV-EA(D) IGG ELISA TEST
- K941198 — EBV LGG ELISA TEST
- K946157 — INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT
- K946159 — INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KIT
- K934774 — UNKNOWN
- K931443 — ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS
- K925688 — MERIDIAN EBV-EA TEST KIT
- K921628 — EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA
- K922332 — BARTELS EPSTEIN-BARR VIRUS IGG EIA
- K912488 — FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS
- K912489 — COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS
- K903612 — EBV/EA-CHECK TM TEST KIT
- K895652 — EBV-EA IFA KIT
- K894932 — FIAX EB VCA-M TEST KIT
- K894235 — EB VCA STAT M TEST KIT
- K883870 — EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590
- K883871 — EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590
- K891086 — STAT TEST KIT FOR EB-VCA IGG ANTIBODY
- K882447 — EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TES
- K882023 — FIAX TEST KIT FOR EB-VCA-G ANTIBODY
- K881617 — INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY
- K872617 — EBV-EA TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.