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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Trinity Biotech - 05391516743570

Captia™ EBNA-1 IgG
CLARK LABORATORIES, INC.
2325800
In Commercial Distribution

  • 05391516743570 ()

  • 96 Tests
2325800

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516743365

Captia™ EBV EA-D IgG
CLARK LABORATORIES, INC.
2325000
In Commercial Distribution

  • 05391516743365 ()

  • 96 Tests
2325000

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516743334

Captia™ EBV VCA P-18 IgG
CLARK LABORATORIES, INC.
2324700
In Commercial Distribution

  • 05391516743334 ()

  • 96 Tests
2324700

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ReQuest - 00850487007180

Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
EB VCA G
In Commercial Distribution

  • 00850487007180 ()
Q01-470

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

SeraQuest - 00850487007371

Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
EB VCA G
In Commercial Distribution

  • 00850487007371 ()
Q01-470

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

QMedix™ - 00850054026613

QMedix™ EBV VCA IgG ImmunoFlourescent Assay
Diagnostic Automation, Inc.
DACD401010-G
In Commercial Distribution

  • 00850054026613 ()

  • 10, 10-well slides
401010-G

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

FITC Anti-IgG Primary Antibody - 04015630971497

No Description
Ventana Medical Systems, Inc.
05267919001
In Commercial Distribution

  • 04015630971497 ()
05267919001

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD

CHORUS ECHINOCOCCUS IgG - 08033891320010

No Description
DIESSE DIAGNOSTICA SENESE SPA
81284
In Commercial Distribution

  • 08033891320010 ()
81284

  • Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-Echinococcus EUROLINE WB (IgG) - 04049016116110

No Description
EUROIMMUN Medizinische Labordiagnostika AG
DY 2321-1601-1 G
In Commercial Distribution

  • 04049016116110 ()


  • Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-Echinococcus ELISA (IgG) - 04049016117124

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2320-9601-1 G
In Commercial Distribution

  • 04049016117124 ()


  • Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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