ClearanceBrief
Panels › Microbiology › Product code LLM · Class 1

Test, Antigen, Nuclear, Epstein-Barr Virus

Regulation 866.3235

0510(k)s in 12 months (27 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
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Top companies in LLM

Decided510(k)Device and applicantCode
Aug 7, 2024K233605ADVIA Centaur EBV-EBNA IgG
Biokit, S.A., ES
LLM
Apr 29, 2005K040120DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS
DiaSorin, Inc.
LLM
Jan 11, 1999K984133THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
Zeus Scientific, Inc.
LLM
Aug 10, 1998K973941IMMUNOWELL EBNA IGG TEST
Genbio
LLM
May 1, 1998K980598EBNA-1 IGM ELISA TEST SYSTEM
Clark Laboratories, Inc.
LLM
Apr 29, 1996K951549EBNA IGG EIA TEST SYSTEM
Immunoprobe, Inc.
LLM
Feb 15, 1996K951822EBNA ENZYME IMMUNOASSAY KIT
Granbio, Inc.
LLM
Sep 19, 1995K935730EBNA IGG ELISA TEST
Gull Laboratories, Inc.
LLM
Jul 21, 1995K946353EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY
Mrl Diagnostics
LLM
Jun 9, 1995K946158INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT
Incstar Corp.
LLM
May 5, 1995K932742EBNA IGG ELISA TEST SYSTEM
Zeus Scientific, Inc.
LLM
Oct 12, 1993K925690MERIDIAN EBNA TEST KIT
Fuller Laboratories, Inc.
LLM
Jul 16, 1993K930002ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA
Ortho Diagnostic Systems, Inc.
LLM
Sep 25, 1991K911473EBNA STAT TEST KIT
Whittaker Bioproducts, Inc.
LLM
Jun 10, 1991K911569EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST
Ortho Diagnostic Systems, Inc.
LLM
Dec 11, 1989K895708EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI)
Immuno Concepts, Inc.
LLM
Dec 8, 1989K895707EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY)
Immuno Concepts, Inc.
LLM
Oct 16, 1989K894626EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN
Bion Ent., Ltd.
LLM
Jun 20, 1989K891542EBNA-CHECK(TM) TEST KIT
Diagnostic Technology, Inc.
LLM
May 11, 1989K883601EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550
Clinical Sciences, Inc.
LLM
May 11, 1989K883600EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550
Clinical Sciences, Inc.
LLM
Dec 15, 1988K882440EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN ANTIBODY TEST
Zeus Scientific, Inc.
LLM
Aug 30, 1988K875203DU PONT EBNA-IGG ANTIBODY ELISA KIT
E.I. Dupont DE Nemours & Co., Inc.
LLM
May 23, 1988K875170EBNA ANTIBODY
Hillcrest Biologicals
LLM
Mar 24, 1988K880043EBV-NA TEST
Gull Laboratories, Inc.
LLM
Jun 25, 1987K871298EBNA ACIF ASSAY KIT
Granbio, Inc.
LLM
Dec 27, 1984K840417EBNA ACIF KIT
Litton Bionetics
LLM

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