Atlas FDA

LSE

56 FDA 510(k) clearances · Product code

144 daysmedian time to decision
314 days90th percentile
56clearances measured

FDA profile

Official device name
Epstein-Barr Virus, Other
Device class
Class I (low risk)
Regulation
21 CFR 866.3235
Medical specialty
Microbiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2003: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
ADVIA Centaur EBV-VCA IgM (K233606)Biokit, S.A.2024-08-07
LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set (K162961)DiaSorin, Inc.2017-01-05
LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set (K162959)DiaSorin, Inc.2017-01-04
SERAQUEST EBV EA-D IGG TEST (K091260)Quest Intl., Inc.2009-06-08
PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G (K073382)Focus Diagnostics, Inc.2008-07-28
BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K062211)Bio-Rad Laboratories, Inc.2006-12-08
BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K062213)Bio-Rad Laboratories, Inc.2006-12-08
LIAISON EA IGG (K060204)DiaSorin, Inc.2006-10-18
MODIFICATION TO SERAQUEST EB VCA IGG (K033915)Quest Intl., Inc.2004-01-16
EBV VCA-P18 IGG ELISA (K030863)Panbio Limited2003-06-27
EBV EA-D IGG ELISA KIT, MODEL EBG-100 (K021793)Pan Bio Pty. , Ltd.2002-09-27
IMMUNOWELL EA (D) IGG TEST (K010301)Genbio2001-06-11
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM (K992587)Stellar Bio Systems, Inc.1999-12-22
SERAQUEST EB NA IGG (K991975)Quest Intl., Inc.1999-11-02
SERAQUEST EB VCA IGG (K990410)Quest Intl., Inc.1999-10-28
ETI-EA-G ASSAY (K992191)DiaSorin, Inc.1999-07-12
BIOTEST ANTI-EBV RECOMBINANT (K983839)Biotest Diagnostics Corp.1999-06-09
BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG (K983841)Biotest Diagnostics Corp.1999-06-09
BIOTEST ANTI-EBV RECOMBINANT, EA IGM (K983842)Biotest Diagnostics Corp.1999-06-09
COPALIS MULTIPLEX EBV ANTIBODY ASSAY (K991660)DiaSorin, Inc.1999-06-04
EBV-VCA IGG ELISA TEST SYSTEM (K981812)Diamedix Corp.1999-03-04
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO (K983801)Zeus Scientific, Inc.1998-12-10
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR (K983804)Zeus Scientific, Inc.1998-12-08
EA-D IGM ELISA TEST SYSTEM (K982350)Columbia Bioscience, Inc.1998-11-25
EBNA-1 IGM ELISA TEST SYSTEM (K982348)Columbia Bioscience, Inc.1998-11-25
VCA IGM ELISA TEST SYSTEM (K982352)Columbia Bioscience, Inc.1998-11-25
IMMUNODOT MONO-G TEST (K974226)Genbio1998-09-22
IMMUNODOT MONO-M TEST (K974244)Genbio1998-09-22
ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA (K981120)Zeus Scientific, Inc.1998-08-21
IMMUNOWELL EBV VCA IGG TEST (K973940)Genbio1998-08-10
VCA IGM ELISA TEST SYSTEM (K980596)Clark Laboratories, Inc.1998-07-22
VCA IGG ELISA TEST SYSTEM (K980912)Clark Laboratories, Inc.1998-07-22
EA-D IGG ELISA TEST SYSTEM (K973123)Clark Laboratories, Inc.1998-03-26
EBV-VCA IGM ELISA TEST STSTEM (K944449)Zeus Scientific, Inc.1995-09-25
EBV-EA(D) IGG ELISA TEST (K940093)Gull Laboratories, Inc.1995-09-15
EBV LGG ELISA TEST (K941198)Gull Laboratories, Inc.1995-08-23
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KIT (K946159)Incstar Corp.1995-06-07
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT (K946157)Incstar Corp.1995-06-07
UNKNOWN (K934774)Granbio, Inc.1994-04-20
ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS (K931443)Ortho Diagnostic Systems, Inc.1993-11-05
MERIDIAN EBV-EA TEST KIT (K925688)Fuller Laboratories, Inc.1993-10-12
EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA (K921628)Incstar Corp.1992-09-14
BARTELS EPSTEIN-BARR VIRUS IGG EIA (K922332)Baxter Diagnostics, Inc.1992-09-02
COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS (K912489)Immuno Concepts, Inc.1991-07-24
FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS (K912488)Immuno Concepts, Inc.1991-07-24
EBV/EA-CHECK TM TEST KIT (K903612)Diagnostic Technology, Inc.1990-10-16
EBV-EA IFA KIT (K895652)Organon Teknika Treyburn1989-12-18
FIAX EB VCA-M TEST KIT (K894932)Whittaker Bioproducts, Inc.1989-10-16
EB VCA STAT M TEST KIT (K894235)Whittaker Bioproducts, Inc.1989-08-30
EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590 (K883871)Clinical Sciences, Inc.1989-07-14
EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590 (K883870)Clinical Sciences, Inc.1989-07-14
STAT TEST KIT FOR EB-VCA IGG ANTIBODY (K891086)Whittaker Bioproducts, Inc.1989-05-10
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TES (K882447)Zeus Scientific, Inc.1988-12-15
FIAX TEST KIT FOR EB-VCA-G ANTIBODY (K882023)Whittaker Bioproducts, Inc.1988-08-03
INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY (K881617)Granbio, Inc.1988-06-07
EBV-EA TEST (K872617)Gull Laboratories, Inc.1988-01-05

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