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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
Roche Diagnostics GmbH
4618823160
In Commercial Distribution

  • 04015630939343 ()
4618823160

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
No Description
DIASORIN MOLECULAR LLC
EL0300G-5
In Commercial Distribution

  • 20816101022018 ()
EL0300G-5

  • West Nile virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN MOLECULAR LLC
EL0300G
In Commercial Distribution

  • 20816101022001 ()
EL0300G

  • West Nile virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The SeroELISA Chlamydia IgG kit is intended for the determination of specific IgG antibody to Chlamydia in a single human serum sample or to evaluate paired sera, by an Enzyme-Linked Immunosorbent Assay (ELISA).
SAVYON DIAGNOSTICS LTD
A111-01
In Commercial Distribution

  • 07290001913147 ()
A111-01

  • Chlamydia pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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
Gold Standard Diagnostics Influenza B IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3010
In Commercial Distribution

  • B350GSD0130100 ()
GSD01-3010

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Influenza A IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3009
In Commercial Distribution

  • B350GSD0130090 ()
GSD01-3009

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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)
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