Product code LJN— Microbiology
(EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM
- Classification name
- Antibody Igm, If, Epstein-Barr Virus
- Device class
- Class 1
- Regulation
- 21 CFR 866.3235
- Advisory panel
- Microbiology
- Total cleared
- 23
- First cleared
- Most recent
Market context for product code LJN
FDA has cleared devices under product code LJN between 1983 and 2012, filed by 18 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- 2012
- 2008
- 2005
- 2004
- 1999
- 1998
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1983
Top applicants under product code LJN
Recent clearances under product code LJN
- K123021 — BIOPLEX 2200 EBV IGM KIT
- K073381 — PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M
- K042092 — ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
- K033780 — MODIFICATION TO SERAQUEST VCA IGM
- K990977 — SERAQUEST EB VAC IGM
- K991459 — COPALIS EBV-M ANTIBODY ASSAY
- K973939 — IMMUNOWELL VCA IGM TEST
- K931520 — EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY
- K930020 — ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA
- K922331 — BARTELS EPSTEIN-BARR VIRUS IGM EIA
- K915348 — EBV-VCA IGM ELISA
- K911362 — AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST
- K910042 — EBV IGM ELISA TEST
- K901840 — (EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM
- K896594 — EBV VCA ANTIBODY (IGM)
- K893240 — BION EBV-M (VCA) TEST SYSTEM
- K890639 — RESUBMITTED EBV/IGM-CHECK TEST KIT
- K880884 — EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME)
- K880886 — EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT)
- K875204 — DU PONT VCA-IGM ANTIBODY ELISA KIT
- K872541 — ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO.
- K864604 — EBV VCA IGM ANTIBODY ASSAY KIT
- K833014 — EBV-VCA-IGM IFA TEST SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.