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.
1N40C5-10-US
In Commercial Distribution

  • 06921963715258 ()
  • 06921963712943 ()


  • 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.
1N40C5-40-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
D AND C PACK
Cardinal Health 200, LLC
SMACGDCSCF
In Commercial Distribution

  • 50195594002839 ()
  • 10195594002831 ()
SMACGDCSCF

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
D AND C PACK 10004297
Cardinal Health 200, LLC
SMAHFDCFTB
In Commercial Distribution

  • 50195594041241 ()
  • 10195594041243 ()
SMAHFDCFTB

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
D AND C PACK
Cardinal Health 200, LLC
SMA4LDCGRD
In Commercial Distribution

  • 50195594039682 ()
  • 10195594039684 ()
SMA4LDCGRD

  • Obstetrical/gynaecological surgical procedure kit, medicated
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