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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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Gold Standard Diagnostics Helicobacter pylori IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-1000
In Commercial Distribution

  • B350GSD0110000 ()


  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoSimplicity Varicella Zoster Virus (Is-VZV) IgG ELISA test for the qualitative and semi-quantitative detection of IgG antibodies to VZV to determine a prior exposure to VZV and to aid in the determination of acute or convalescent stage of VZV infection.
Gold Standard Diagnostics Corporation
720-380
In Commercial Distribution

  • B3507203800 ()
720-380

  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
ACCURUN 190 Anti - Trypanosoma cruzi 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2015-0097
In Commercial Distribution

  • 00816784020499 ()
2015-0097

  • Trypanosoma cruzi immunoglobulin G (IgG) antibody IVD, control
ACCURUN 135 Toxoplasma IgG 1 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0082
In Commercial Distribution

  • 00816784020390 ()
2015-0082

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
No Description
MONOBIND, INC.
1425-300
In Commercial Distribution

  • 00816870021102 ()

  • Width: 7.75 Inch
1425-300A

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
"720-650 EBV-EA-D IgM Test Kit"
DIAMEDIX CORPORATION
720-650
In Commercial Distribution

  • 00817273020365 ()


  • Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot
"720-620 EBNA-1 IgG Test Kit"
DIAMEDIX CORPORATION
720-620
In Commercial Distribution

  • 00817273020334 ()


  • Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot
"720-600 EBV-VCA IgG Test Kit"
DIAMEDIX CORPORATION
720-600
In Commercial Distribution

  • 00817273020310 ()


  • Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot
No Description
SCIMEDX CORPORATION
I-RSV01X
In Commercial Distribution

  • 00813545026134 ()
I-RSV01X

  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
SCIMEDX CORPORATION
I-RSV01G
In Commercial Distribution

  • 00813545026127 ()
I-RSV01G

  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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