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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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Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
HSV Type 2 G
In Commercial Distribution

  • 00850487007555 ()
Q01-420

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
HSV Type 1 G
In Commercial Distribution

  • 00850487007548 ()
01-410

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
HSV Type 1 G
In Commercial Distribution

  • 00850487007135 ()
01-410

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
HSV Type 2 G
In Commercial Distribution

  • 00850487007128 ()
Q01-420

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
TOXO G
In Commercial Distribution

  • 00850487007036 ()
Q01-120

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
AccuDiag ™ Herpes Simplex 1 IgG (HSV 1 IgG) ELISA
Diagnostic Automation, Inc.
DACD1401-2
In Commercial Distribution

  • 00850054026095 ()

  • 96 Tests
1401-2

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
AccuDiag ™Herpes Simplex 2 IgG (HSV 2 IgG) ELISA
Diagnostic Automation, Inc.
DACD1403-2
In Commercial Distribution

  • 00850054026088 ()

  • 96 Tests
1403-2

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QMedix™Toxoplasma Gondii IgG ELISA Kit This test is intended for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the parasitic protozoan Toxoplasma gondii in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD1101-1
In Commercial Distribution

  • 00850054026002 ()

  • 96 tests
1101-1

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Lyme Disease Positive Control is intended for use with in vitro assays, for determination of IgG antibodies to Borrelia burgdorferi and IgM antibodies to Borrelia burgdorferi. Lyme Disease Positive Control is unassayed without target values and is suitable for use on many analysers.
RANDOX LABORATORIES LIMITED
SR10346
In Commercial Distribution

  • 05055273216394 ()
SR10346

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control
Lyme Disease Negative Control is intended for use as an unassayed non-reactive quality assurance reagent, with in vitro assays detecting IgG antibodies to Borrelia burgdorferi and IgM antibodies to Borrelia burgdorferi.
RANDOX LABORATORIES LIMITED
SR10345
In Commercial Distribution

  • 05055273216387 ()
SR10345

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control
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