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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 SARS-CoV-2 IgG ELISA Test Kit for the qualitative detection of IgG antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19).
Gold Standard Diagnostics Corporation
GSD01-1028
Not in Commercial Distribution

  • B350GSD0110280 ()
GSD01-1028

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Echinococcus IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Echinococcus in human serum and plasma. This assay is intended for in vitro diagnostic use only.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
20-EGGHU-E01
In Commercial Distribution

  • B24220EGGHUE010 ()
20-EGGHU-E01

  • Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
12525-300
In Commercial Distribution

  • 00816870024875 ()

  • Width: 7.75 Inch
12525-300B

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
12525-300
In Commercial Distribution

  • 00816870024868 ()

  • Width: 7.75 Inch
12525-300A

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
11925-300
In Commercial Distribution

  • 00816870023601 ()

  • Width: 7.75 Inch
11925-300B

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
11925-300
In Commercial Distribution

  • 00816870023595 ()

  • Width: 7.75 Inch
11925-300A

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
"720-640 EBV-EA-D IgG Test Kit"
DIAMEDIX CORPORATION
720-640
In Commercial Distribution

  • 00817273020358 ()


  • Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
"720-460 anti-TG IgG Test Kit"
DIAMEDIX CORPORATION
720-460
In Commercial Distribution

  • 00817273020273 ()


  • Echinococcus multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
"720-450 anti-TPO IgG Test Kit"
DIAMEDIX CORPORATION
720-450
In Commercial Distribution

  • 00817273020266 ()


  • Echinococcus multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
"720-440 anti-PR-3 (C-ANCA) IgG Test Kit"
DIAMEDIX CORPORATION
720-440
In Commercial Distribution

  • 00817273020259 ()


  • Echinococcus multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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