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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 - 10758750034420

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

VITROS - 10758750034413

VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6199960
In Commercial Distribution

  • 10758750034413 ()
6199960

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

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

AEMT KIT - M6898811201010

AEMT KIT SWAT-T Tourniquet 1 ea Celox Rapid 1 ea Duct Tape 1 ea
Safeguard US Operating, LLC
04
In Commercial Distribution

  • M6898811201010 ()
88-112-01

  • First aid kit, non-medicated, single-use

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 - 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
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