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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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No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2290-9601 G
In Commercial Distribution

  • 04049016131601 ()


  • Strongyloides stercoralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2532-9601-24 G
Not in Commercial Distribution

  • 04049016096733 ()


  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2531-9601-24 G
Not in Commercial Distribution

  • 04049016096726 ()


  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
HSV Type 2 Specific IgG EIA Test Set
Bio-RAD Laboratories, Inc.
12008531
In Commercial Distribution

  • 03610522051236 ()

  • 96 Tests
12008531

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
HSV Type 1 Specific IgG EIA Test Set
Bio-RAD Laboratories, Inc.
12008533
In Commercial Distribution

  • 03610522051076 ()

  • 96 Tests
12008533

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
BioPlex 2200 Lyme Total Control CD
BIO-RAD LABORATORIES, INC.
12000880
In Commercial Distribution

  • 03610520506431 ()

  • 1 Each
12000880

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control
BioPlex 2200 Lyme Total Control Set
BIO-RAD LABORATORIES, INC.
12000879
In Commercial Distribution

  • 03610520506424 ()

  • Total Volume: 1.5 Milliliter
  • 6 Vials
12000879

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control
No Description
DIASORIN MOLECULAR LLC
EL0907
In Commercial Distribution

  • 10816101022110 ()
EL0907

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, calibrator
No Description
DIASORIN MOLECULAR LLC
EL0903
In Commercial Distribution

  • 10816101022073 ()
EL0903

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, calibrator
The ZEUS ELISA Toxoplasma gondii IgG Test System is designed for the qualitative and/or quantitative determination of IgG antibodies to Toxoplasma gondii in human serum. The assay is intended to be used to evaluate serologic evidence of previous infection with T. gondii, and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in screening blood or plasma donors.
ZEUS SCIENTIFIC, INC.
SM8Z8651G
In Commercial Distribution

  • 00845533001212 ()
SM8Z8651G

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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