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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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VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6199951
In Commercial Distribution

  • 20758750033604 ()
  • 10758750033607 ()
6199951

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator
ORTHO CLINICAL DIAGNOSTICS
6199920
In Commercial Distribution

  • 10758750033362 ()
6199920

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6199919
In Commercial Distribution

  • 10758750033355 ()
6199919

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Calibrator
ORTHO CLINICAL DIAGNOSTICS
6199961
In Commercial Distribution

  • 10758750034420 ()
6199961

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
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)
No Description
INBIOS INTERNATIONAL, INC
COVE-G
In Commercial Distribution

  • B379COVEG1 ()


  • SARS-CoV-2 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)
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