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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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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 - 00380740192112

SARS-CoV-2 IgG Control Kit
ABBOTT LABORATORIES
06R9010
In Commercial Distribution

  • 00380740192112 ()
06R9010

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

Alinity - 00380740192105

SARS-CoV-2 IgG Calibrator Kit
ABBOTT LABORATORIES
06R9001
In Commercial Distribution

  • 00380740192105 ()
06R9001

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator

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

Alinity - 00380740192075

AdviseDx SARS-CoV-2 IgM Control Kit
Abbott Ireland Diagnostics
06R9110
In Commercial Distribution

  • 00380740192075 ()
06R9110

  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, control

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

ARCHITECT - 00380740191849

AdviseDx SARS-CoV-2 IgM Calibrator Kit
Abbott Ireland Diagnostics
06R8701
In Commercial Distribution

  • 00380740191849 ()
06R8701

  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, calibrator
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