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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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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.
1N40C5-40-US
In Commercial Distribution

  • 06921963715258 ()
  • 06921963712936 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
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.
1N40C5-8-US
In Commercial Distribution

  • 06921963715258 ()
  • 06921963712929 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
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
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.
1N40C5-5-US
In Commercial Distribution

  • 06921963715258 ()
  • 06921963712516 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
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.
1N40C5-2-US
In Commercial Distribution

  • 06921963712509 ()
  • 06921963715258 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
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.
1N40C5-1-US
In Commercial Distribution

  • 06921963712493 ()
  • 16921963712490 ()


  • 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
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