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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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Anti-SARS-CoV-2 ELISA (IgG) - 04049016145554

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2606-9601 G
In Commercial Distribution

  • 04049016145554 ()


  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-SARS-CoV-2 S1 Curve ELISA (IgG) - 04049016150244

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2606-9601-20 G
Not in Commercial Distribution

  • 04049016150244 ()


  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

VITROS - 10758750033362

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 - 10758750033355

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

LIAISON® SARS-CoV-2 S1/S2 IgG - 08056771103664

No Description
DIASORIN SPA
311460
In Commercial Distribution

  • 08056771103664 ()


  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Alinity - 00380740193867

AdviseDx SARS-CoV-2 IgG II Reagent Kit 1000 Test
Abbott Ireland Diagnostics
06S6130
In Commercial Distribution

  • 00380740193867 ()
06S6130

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Alinity - 00380740193843

AdviseDx SARS-CoV-2 IgG II Reagent Kit 200 Test
Abbott Ireland Diagnostics
06S6120
In Commercial Distribution

  • 00380740193843 ()
06S6120

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

ARCHITECT - 00380740193782

AdviseDx SARS-CoV-2 IgG II Reagent Kit 500 Test
Abbott Ireland Diagnostics
06S6030
In Commercial Distribution

  • 00380740193782 ()
06S6030

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

ARCHITECT - 00380740193768

AdviseDx SARS-CoV-2 IgG II Reagent Kit 100 Test
Abbott Ireland Diagnostics
06S6020
In Commercial Distribution

  • 00380740193768 ()
06S6020

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

ARCHITECT - 00380740192150

SARS-CoV-2 IgG Reagent Kit 500 Tests
ABBOTT LABORATORIES
06R8630
In Commercial Distribution

  • 00380740192150 ()
06R8630

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
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