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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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90 Test Kit SARS-CoV-2 IgG Immunoassay
QUALIGEN INC.
SARS-CoV-2 IgG Immunoassay
In Commercial Distribution

  • 00816467020389 ()
  • 10816467020386 ()
25000085

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
OSOM COVID-19 Antigen Control Kit
SEKISUI DIAGNOSTICS, LLC
1068
In Commercial Distribution

  • 00742860000034 ()
  • 10742860000031 ()
1068

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
AdviseDx SARS-CoV-2 IgG II Control Kit
Abbott Ireland Diagnostics
06S6110
In Commercial Distribution

  • 00380740193829 ()
06S6110

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
AdviseDx SARS-CoV-2 IgG II Control Kit
Abbott Ireland Diagnostics
06S6010
In Commercial Distribution

  • 00380740193744 ()
06S6010

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
SARS-CoV-2 IgG Control Kit
ABBOTT LABORATORIES
06R9010
In Commercial Distribution

  • 00380740192112 ()
06R9010

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
SARS-CoV-2 IgG Control Kit
ABBOTT LABORATORIES
06R8610
In Commercial Distribution

  • 00380740191825 ()
06R8610

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Controls
ORTHO CLINICAL DIAGNOSTICS
6199921
In Commercial Distribution

  • 10758750033379 ()
6199921

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
The Access SARS-CoV-2 IgG II QC is intended for monitoring system performance of the Access SARS-CoV-2 IgG II assay using the Access Immunoassay Systems only. The Access SARS-CoV-2 IgG II QC are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C69059
In Commercial Distribution

  • 15099590742768 ()
C69059

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
The Access SARS-CoV-2 IgG QC is intended for monitoring system performance of the Access SARS-CoV-2 IgG assay. The Access SARS-CoV-2 IgG QC is for use on the Access Family of Immunoassay Systems only. The Access SARS-CoV-2 IgG QC are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58964
In Commercial Distribution

  • 15099590738662 ()
C58964

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
AdviseDx SARS-CoV-2 IgG II Calibrator Kit
Abbott Ireland Diagnostics
06S6101
In Commercial Distribution

  • 00380740193805 ()
06S6101

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