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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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Genabio Diagnostics Inc.
RA9-E00325
In Commercial Distribution

  • 00860008954862 ()
  • 00860008954824 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
COVID-19 antigen self home test in vitro diagnostic use only (1 Test Kit/Box)
BIOTEKE USA, LLC
BTK-H2201
In Commercial Distribution



  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Hotgen™ COVID-19 Antigen Home Test (Model: 40T/kit)
Beijing Hotgen Biotech Co., Ltd.
40T/kit
In Commercial Distribution

  • 06936700405248 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Hotgen™ COVID-19 Antigen Home Test (Model: 20T/kit)
Beijing Hotgen Biotech Co., Ltd.
20T/kit
In Commercial Distribution

  • 06936700405231 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Hotgen™ COVID-19 Antigen Home Test (Model: 10T/kit)
Beijing Hotgen Biotech Co., Ltd.
10T/kit
In Commercial Distribution

  • 06936700405224 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Hotgen™ COVID-19 Antigen Home Test (Model: 5T/kit)
Beijing Hotgen Biotech Co., Ltd.
5T/kit
In Commercial Distribution

  • 06936700405217 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Hotgen™ COVID-19 Antigen Home Test (Model: 1T/kit)
Beijing Hotgen Biotech Co., Ltd.
1T/kit
In Commercial Distribution

  • 06936700405200 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Hotgen™ COVID-19 Antigen Home Test (Model: 2T/Kit)
Beijing Hotgen Biotech Co., Ltd.
2T/Kit
In Commercial Distribution

  • 06936700403916 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
COVID-19 antigen self home test in vitro diagnostic use only (5 Test Kits/Box)
BIOTEKE USA, LLC
BTK-H2205
In Commercial Distribution



  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
COVID-19 antigen self home test in vitro diagnostic use only (2 Test Kits/Box)
BIOTEKE USA, LLC
BTK-H2202
In Commercial Distribution



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