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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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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 - 00380740192167

AdviseDx SARS-CoV-2 IgM Reagent Kit 500 Test
Abbott Ireland Diagnostics
06R8730
In Commercial Distribution

  • 00380740192167 ()
06R8730

  • SARS-CoV-2 immunoglobulin M (IgM) 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

Alinity - 00380740192136

SARS-CoV-2 IgG Reagent Kit 1000 Tests
ABBOTT LABORATORIES
06R9030
In Commercial Distribution

  • 00380740192136 ()
06R9030

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

Alinity - 00380740192129

SARS-CoV-2 IgG Reagent Kit 200 Tests
ABBOTT LABORATORIES
06R9020
In Commercial Distribution

  • 00380740192129 ()
06R9020

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

Alinity - 00380740192099

AdviseDx SARS-CoV-2 IgM Reagent Kit 1000 Test
Abbott Ireland Diagnostics
06R9130
In Commercial Distribution

  • 00380740192099 ()
06R9130

  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Alinity - 00380740192082

AdviseDx SARS-CoV-2 IgM Reagent Kit 200 Test
Abbott Ireland Diagnostics
06R9120
In Commercial Distribution

  • 00380740192082 ()
06R9120

  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

ARCHITECT - 00380740191863

AdviseDx SARS-CoV-2 IgM Reagent Kit 100 Test
Abbott Ireland Diagnostics
06R8720
In Commercial Distribution

  • 00380740191863 ()
06R8720

  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
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