LLM · Class I · 21 CFR 866.3235

FDA Product Code LLM: Test, Antigen, Nuclear, Epstein-barr Virus

Leading manufacturers include Zeus Scientific, Inc., Gull Laboratories, Inc. and Immuno Concepts, Inc..

27
Total
27
Cleared
234d
Avg days
1984
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Test, Antigen, Nuclear, Epstein-barr Virus Devices (Product Code LLM)

27 devices
1–24 of 27
Cleared Aug 07, 2024
ADVIA Centaur EBV-EBNA IgG
K233605
Biokit, S.A.
Microbiology · 272d
Cleared Apr 29, 2005
DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS
K040120
DiaSorin, Inc.
Microbiology · 465d
Cleared Jan 11, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
K984133
Zeus Scientific, Inc.
Microbiology · 54d
Cleared Sep 19, 1995
EBNA IGG ELISA TEST
K935730
Gull Laboratories, Inc.
Microbiology · 657d
Cleared Jun 09, 1995
INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT
K946158
Incstar Corp.
Microbiology · 183d
Cleared May 05, 1995
EBNA IGG ELISA TEST SYSTEM
K932742
Zeus Scientific, Inc.
Microbiology · 696d
Cleared Jul 16, 1993
ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA
K930002
Ortho Diagnostic Systems, Inc.
Microbiology · 193d
Cleared Jun 10, 1991
EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST
K911569
Ortho Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Dec 11, 1989
EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI)
K895708
Immuno Concepts, Inc.
Microbiology · 77d
Cleared Dec 08, 1989
EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY)
K895707
Immuno Concepts, Inc.
Microbiology · 74d
Cleared Dec 15, 1988
EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN ANTIBODY TEST
K882440
Zeus Scientific, Inc.
Microbiology · 184d
Cleared Aug 30, 1988
DU PONT EBNA-IGG ANTIBODY ELISA KIT
K875203
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 256d
Cleared Mar 24, 1988
EBV-NA TEST
K880043
Gull Laboratories, Inc.
Microbiology · 78d

About Product Code LLM - Regulatory Context

510(k) Submission Activity

27 total 510(k) submissions under product code LLM since 1984, with 27 receiving FDA clearance (average review time: 234 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.