Atlas FDA

LLM

27 FDA 510(k) clearances · Product code

193 daysmedian time to decision
465 days90th percentile
27clearances measured

FDA profile

Official device name
Test, Antigen, Nuclear, Epstein-Barr Virus
Device class
Class I (low risk)
Regulation
21 CFR 866.3235
Medical specialty
Microbiology
Flags
Third-party review eligible
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RecordFirmDate
ADVIA Centaur EBV-EBNA IgG (K233605)Biokit, S.A.2024-08-07
DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS (K040120)DiaSorin, Inc.2005-04-29
THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH (K984133)Zeus Scientific, Inc.1999-01-11
IMMUNOWELL EBNA IGG TEST (K973941)Genbio1998-08-10
EBNA-1 IGM ELISA TEST SYSTEM (K980598)Clark Laboratories, Inc.1998-05-01
EBNA IGG EIA TEST SYSTEM (K951549)Immunoprobe, Inc.1996-04-29
EBNA ENZYME IMMUNOASSAY KIT (K951822)Granbio, Inc.1996-02-15
EBNA IGG ELISA TEST (K935730)Gull Laboratories, Inc.1995-09-19
EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY (K946353)Mrl Diagnostics1995-07-21
INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT (K946158)Incstar Corp.1995-06-09
EBNA IGG ELISA TEST SYSTEM (K932742)Zeus Scientific, Inc.1995-05-05
MERIDIAN EBNA TEST KIT (K925690)Fuller Laboratories, Inc.1993-10-12
ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA (K930002)Ortho Diagnostic Systems, Inc.1993-07-16
EBNA STAT TEST KIT (K911473)Whittaker Bioproducts, Inc.1991-09-25
EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST (K911569)Ortho Diagnostic Systems, Inc.1991-06-10
EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI) (K895708)Immuno Concepts, Inc.1989-12-11
EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY) (K895707)Immuno Concepts, Inc.1989-12-08
EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN (K894626)Bion Ent., Ltd.1989-10-16
EBNA-CHECK(TM) TEST KIT (K891542)Diagnostic Technology, Inc.1989-06-20
EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550 (K883601)Clinical Sciences, Inc.1989-05-11
EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550 (K883600)Clinical Sciences, Inc.1989-05-11
EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN ANTIBODY TEST (K882440)Zeus Scientific, Inc.1988-12-15
DU PONT EBNA-IGG ANTIBODY ELISA KIT (K875203)E.I. Dupont DE Nemours & Co., Inc.1988-08-30
EBNA ANTIBODY (K875170)Hillcrest Biologicals1988-05-23
EBV-NA TEST (K880043)Gull Laboratories, Inc.1988-03-24
EBNA ACIF ASSAY KIT (K871298)Granbio, Inc.1987-06-25
EBNA ACIF KIT (K840417)Litton Bionetics1984-12-27

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Every clearance here is in the API, with alerts when new ones post.