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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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Reagent Red Blood Cells (Pooled Cells) Ortho® Coombs Control
ORTHO-CLINICAL DIAGNOSTICS, INC.
719810
In Commercial Distribution

  • 10758750004072 ()
719810

  • Immunoglobulin-sensitized reagent red blood cell IVD, control
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2311-9601 G
In Commercial Distribution

  • 04049016141112 ()


  • Toxocara canis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2300-9601 G
In Commercial Distribution

  • 04049016135449 ()


  • Schistosoma mansoni immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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)
VIDAS ® TOXO IgG Avidity assay is a qualitative IA intended for use on VIDAS family instrument for the determination of anti - toxoplasma IgG avidity in human serum.
BIOMERIEUX SA
30222-01
In Commercial Distribution

  • 03573026263010 ()


  • Toxoplasma gondii immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)
TOXO IgG II (TXG) assay is a quantitative IA intended for use on VIDAS family instrument in the detection of anti - toxoplasma IgG concentration in human serum or plasma.
BIOMERIEUX SA
30210-01
In Commercial Distribution

  • 03573026156855 ()


  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Diasorin Inc.
318331
In Commercial Distribution

  • 08056771602716 ()


  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control
No Description
DIASORIN SPA
310542
Not in Commercial Distribution

  • 08056771601795 ()


  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
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