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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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CorDx COVID-19 Ag Test
CORETESTS, INC.
CO291-2
In Commercial Distribution

  • 10850042559120 ()
  • 00850042559123 ()
  • 00850042559116 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx COVID-19 Ag Test
CORETESTS, INC.
CO291-10
In Commercial Distribution

  • 00850042559093 ()
  • 10850042559090 ()
  • 00850042559109 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx COVID-19 Ag Test
CORETESTS, INC.
CO291-5
In Commercial Distribution

  • 00850042559086 ()
  • 10850042559083 ()
  • 00850042559109 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx COVID-19 Ag Test
CORETESTS, INC.
CO291-2
In Commercial Distribution

  • 00850042559079 ()
  • 10850042559076 ()
  • 00850042559109 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2.
NANO-DITECH CORPORATION
MD-8147
In Commercial Distribution

  • 10895160002868 ()
  • 00895160002861 ()
MD-8147 2T

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
An in vitro diagnostic, a time resolved fluorescence lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2.
NANO-DITECH CORPORATION
TF-8150
In Commercial Distribution

  • 10895160002790 ()
  • 00895160002793 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
QuickVue® SARS Antigen Test
QUIDEL CORPORATION
20387
In Commercial Distribution

  • 30014613339373 ()
20387

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
OSOM COVID-19 Antigen Home Test
SEKISUI DIAGNOSTICS, LLC
1067-40
In Commercial Distribution

  • 00742860000041 ()
  • 10742860000000 ()
1067-40

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
OSOM COVID-19 Antigen Rapid Test
SEKISUI DIAGNOSTICS, LLC
1066-40
In Commercial Distribution

  • 00742860000027 ()
  • 10742860000024 ()
1066-40

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
QuickVue At-Home OTC COVID-19 Test
QUIDEL CORPORATION
20402
In Commercial Distribution

  • 30014613339724 ()
20402

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