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Epstein-Barr Virus, Other

FDA product code LSE · 56 cleared devices

Class 1 Microbiology

Regulation: 21 CFR 866.3235
Review panel: MI
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1988-01-05 – 2024-08-07

LSE 2024-08-07

ADVIA Centaur EBV-VCA IgM

Applicant Biokit, S.A.

K number K233606

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LSE 2017-01-05

LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set

Applicant DiaSorin, Inc.

K number K162961

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LSE 2017-01-04

LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set

Applicant DiaSorin, Inc.

K number K162959

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LSE 2009-06-08

SERAQUEST EBV EA-D IGG TEST

Applicant Quest Intl., Inc.

K number K091260

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LSE 2008-07-28

PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G

Applicant Focus Diagnostics, Inc.

K number K073382

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LSE 2006-12-08

BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

Applicant Bio-Rad Laboratories, Inc.

K number K062213

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LSE 2006-12-08

BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

Applicant Bio-Rad Laboratories, Inc.

K number K062211

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LSE 2006-10-18

LIAISON EA IGG

Applicant DiaSorin, Inc.

K number K060204

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LSE 2004-01-16

MODIFICATION TO SERAQUEST EB VCA IGG

Applicant Quest Intl., Inc.

K number K033915

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LSE 2003-06-27

EBV VCA-P18 IGG ELISA

Applicant Panbio Limited

K number K030863

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LSE 2002-09-27

EBV EA-D IGG ELISA KIT, MODEL EBG-100

Applicant Pan Bio Pty. , Ltd.

K number K021793

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LSE 2001-06-11

IMMUNOWELL EA (D) IGG TEST

Applicant Genbio

K number K010301

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LSE 1999-12-22

EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM

Applicant Stellar Bio Systems, Inc.

K number K992587

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LSE 1999-11-02

SERAQUEST EB NA IGG

Applicant Quest Intl., Inc.

K number K991975

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LSE 1999-10-28

SERAQUEST EB VCA IGG

Applicant Quest Intl., Inc.

K number K990410

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LSE 1999-07-12

ETI-EA-G ASSAY

Applicant DiaSorin, Inc.

K number K992191

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LSE 1999-06-09

BIOTEST ANTI-EBV RECOMBINANT, EA IGM

Applicant Biotest Diagnostics Corp.

K number K983842

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LSE 1999-06-09

BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG

Applicant Biotest Diagnostics Corp.

K number K983841

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LSE 1999-06-09

BIOTEST ANTI-EBV RECOMBINANT

Applicant Biotest Diagnostics Corp.

K number K983839

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LSE 1999-06-04

COPALIS MULTIPLEX EBV ANTIBODY ASSAY

Applicant DiaSorin, Inc.

K number K991660

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LSE 1999-03-04

EBV-VCA IGG ELISA TEST SYSTEM

Applicant Diamedix Corp.

K number K981812

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LSE 1998-12-10

THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO

Applicant Zeus Scientific, Inc.

K number K983801

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LSE 1998-12-08

THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR

Applicant Zeus Scientific, Inc.

K number K983804

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LSE 1998-11-25

VCA IGM ELISA TEST SYSTEM

Applicant Columbia Bioscience, Inc.

K number K982352

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LSE 1998-11-25

EA-D IGM ELISA TEST SYSTEM

Applicant Columbia Bioscience, Inc.

K number K982350

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LSE 1998-11-25

EBNA-1 IGM ELISA TEST SYSTEM

Applicant Columbia Bioscience, Inc.

K number K982348

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LSE 1998-09-22

IMMUNODOT MONO-M TEST

Applicant Genbio

K number K974244

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LSE 1998-09-22

IMMUNODOT MONO-G TEST

Applicant Genbio

K number K974226

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LSE 1998-08-21

ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA

Applicant Zeus Scientific, Inc.

K number K981120

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LSE 1998-08-10

IMMUNOWELL EBV VCA IGG TEST

Applicant Genbio

K number K973940

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LSE 1998-07-22

VCA IGG ELISA TEST SYSTEM

Applicant Clark Laboratories, Inc.

K number K980912

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LSE 1998-07-22

VCA IGM ELISA TEST SYSTEM

Applicant Clark Laboratories, Inc.

K number K980596

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LSE 1998-03-26

EA-D IGG ELISA TEST SYSTEM

Applicant Clark Laboratories, Inc.

K number K973123

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LSE 1995-09-25

EBV-VCA IGM ELISA TEST STSTEM

Applicant Zeus Scientific, Inc.

K number K944449

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LSE 1995-09-15

EBV-EA(D) IGG ELISA TEST

Applicant Gull Laboratories, Inc.

K number K940093

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LSE 1995-08-23

EBV LGG ELISA TEST

Applicant Gull Laboratories, Inc.

K number K941198

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LSE 1995-06-07

INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KIT

Applicant Incstar Corp.

K number K946159

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LSE 1995-06-07

INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT

Applicant Incstar Corp.

K number K946157

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LSE 1994-04-20

UNKNOWN

Applicant Granbio, Inc.

K number K934774

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LSE 1993-11-05

ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS

Applicant Ortho Diagnostic Systems, Inc.

K number K931443

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LSE 1993-10-12

MERIDIAN EBV-EA TEST KIT

Applicant Fuller Laboratories, Inc.

K number K925688

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LSE 1992-09-14

EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA

Applicant Incstar Corp.

K number K921628

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LSE 1992-09-02

BARTELS EPSTEIN-BARR VIRUS IGG EIA

Applicant Baxter Diagnostics, Inc.

K number K922332

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LSE 1991-07-24

COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS

Applicant Immuno Concepts, Inc.

K number K912489

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LSE 1991-07-24

FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS

Applicant Immuno Concepts, Inc.

K number K912488

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LSE 1990-10-16

EBV/EA-CHECK TM TEST KIT

Applicant Diagnostic Technology, Inc.

K number K903612

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LSE 1989-12-18

EBV-EA IFA KIT

Applicant Organon Teknika Treyburn

K number K895652

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LSE 1989-10-16

FIAX EB VCA-M TEST KIT

Applicant Whittaker Bioproducts, Inc.

K number K894932

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LSE 1989-08-30

EB VCA STAT M TEST KIT

Applicant Whittaker Bioproducts, Inc.

K number K894235

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LSE 1989-07-14

EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590

Applicant Clinical Sciences, Inc.

K number K883871

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LSE 1989-07-14

EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590

Applicant Clinical Sciences, Inc.

K number K883870

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LSE 1989-05-10

STAT TEST KIT FOR EB-VCA IGG ANTIBODY

Applicant Whittaker Bioproducts, Inc.

K number K891086

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LSE 1988-12-15

EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TES

Applicant Zeus Scientific, Inc.

K number K882447

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LSE 1988-08-03

FIAX TEST KIT FOR EB-VCA-G ANTIBODY

Applicant Whittaker Bioproducts, Inc.

K number K882023

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LSE 1988-06-07

INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY

Applicant Granbio, Inc.

K number K881617

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LSE 1988-01-05

EBV-EA TEST

Applicant Gull Laboratories, Inc.

K number K872617

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