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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 Class Implantable

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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 Calibrator Kit
ABBOTT LABORATORIES
06R9001
In Commercial Distribution

  • 00380740192105 ()
06R9001

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
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
AdviseDx SARS-CoV-2 IgM Calibrator Kit
Abbott Ireland Diagnostics
06R9101
In Commercial Distribution

  • 00380740192068 ()
06R9101

  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, calibrator
AdviseDx SARS-CoV-2 IgM Control Kit
Abbott Ireland Diagnostics
06R8710
In Commercial Distribution

  • 00380740191856 ()
06R8710

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

  • 00380740191825 ()
06R8610

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
SARS-CoV-2 IgG Calibrator Kit
ABBOTT LABORATORIES
06R8601
In Commercial Distribution

  • 00380740191818 ()
06R8601

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
No Description
Shenzhen Yurucheng Dental Materials Co., Ltd.
92×75×20
In Commercial Distribution

  • 06974242680259 ()


  • Dental appliance fabrication material, ceramic
Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
Xiamen Boson Biotech Co., Ltd.
1N40C5-20-US
In Commercial Distribution

  • 06921963715258 ()
  • 06921963712523 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
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