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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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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
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)
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
No Description
DIASORIN SPA
310542
In Commercial Distribution

  • 08056771102995 ()


  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
No Description
DIASORIN SPA
310541
In Commercial Distribution

  • 08056771101813 ()


  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
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)
Strongyloides IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3012
In Commercial Distribution

  • B350GSD0130120 ()
GSD01-3012

  • Strongyloides stercoralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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