LJN · Class I · 21 CFR 866.3235

FDA Product Code LJN: Antibody Igm, If, Epstein-barr Virus

Leading manufacturers include Ortho Diagnostic Systems, Inc., Immuno Concepts, Inc. and Zeus Scientific, Inc..

23
Total
23
Cleared
156d
Avg days
1983
Since

FDA 510(k) Cleared Antibody Igm, If, Epstein-barr Virus Devices (Product Code LJN)

23 devices
1–23 of 23
Cleared Nov 02, 2012
BIOPLEX 2200 EBV IGM KIT
K123021
Bio-Rad Laboratories
Microbiology · 36d
Cleared Apr 12, 2005
ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
K042092
Zeus Scientific, Inc.
Microbiology · 252d
Cleared May 14, 1999
COPALIS EBV-M ANTIBODY ASSAY
K991459
DiaSorin, Inc.
Microbiology · 18d
Cleared Jul 16, 1993
ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA
K930020
Ortho Diagnostic Systems, Inc.
Microbiology · 193d
Cleared Sep 02, 1992
BARTELS EPSTEIN-BARR VIRUS IGM EIA
K922331
Baxter Diagnostics, Inc.
Microbiology · 112d
Cleared Feb 21, 1991
EBV IGM ELISA TEST
K910042
Gull Laboratories, Inc.
Microbiology · 48d
Cleared Jan 16, 1990
EBV VCA ANTIBODY (IGM)
K896594
Hillcrest Biologicals
Microbiology · 56d
Cleared Jun 20, 1989
RESUBMITTED EBV/IGM-CHECK TEST KIT
K890639
Diagnostic Technology, Inc.
Microbiology · 132d
Cleared Aug 30, 1988
EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME)
K880884
Immuno Concepts, Inc.
Microbiology · 181d
Cleared Aug 30, 1988
EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT)
K880886
Immuno Concepts, Inc.
Microbiology · 181d
Cleared Jul 08, 1988
DU PONT VCA-IGM ANTIBODY ELISA KIT
K875204
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 203d
Cleared May 13, 1988
ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO.
K872541
Ortho Diagnostic Systems, Inc.
Microbiology · 319d
Cleared Dec 27, 1983
EBV-VCA-IGM IFA TEST SYSTEM
K833014
Zeus Scientific, Inc.
Immunology · 112d

About Product Code LJN - Regulatory Context