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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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Dimension CV2T Assay
Siemens Healthcare Diagnostics Inc.
11417412
Not in Commercial Distribution

  • 00630414297590 ()
  • 00630414605418 ()
RF812

  • SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay
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.
1N40C5-4-US
In Commercial Distribution

  • 06921963715258 ()
  • 06921963712950 ()
  • 16921963712957 ()


  • 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.
1N40C5-10-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.
1N40C5-1-US
In Commercial Distribution

  • 06921963712493 ()
  • 16921963712490 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
ADVIA Centaur® Zika Ab Assay
Siemens Healthcare Diagnostics Inc.
11200700
Not in Commercial Distribution

  • 00842768026553 ()
11200700

  • Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
ADVIA Centaur Zika Test - Zika Ab Controls
Siemens Healthcare Diagnostics Inc.
11200712
Not in Commercial Distribution

  • 00842768025273 ()
11200712

  • Zika virus immunoglobulin M (IgM) antibody IVD, control
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