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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 - 00850042559093

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 - 00850042559086

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 - 00850042559079

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

Status™ COVID-19 Antigen Rapid Test for Home Use - 10743816001645

Status™ COVID-19 Antigen for Home Use, 25 Test Kit
PRINCETON BIOMEDITECH CORPORATION
BSP-512-25-00
In Commercial Distribution

  • 10743816001645 ()
BSP-512-025-00

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

Status™ COVID-19 Antigen Rapid Test for Home Use - 10743816001638

Status™ COVID-19 Antigen Rapid Test for Home Use, 2 Test Kit
PRINCETON BIOMEDITECH CORPORATION
BSP-512-02-00
In Commercial Distribution

  • 10743816001638 ()
BSP-512-02-00

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

Status™ COVID-19 Antigen Rapid Test for Home Use - 10743816001621

Status™ COVID-19 Antigen Rapid Test for Home Use, 1 Test Kit
PRINCETON BIOMEDITECH CORPORATION
BSP-512-01-00
In Commercial Distribution

  • 10743816001621 ()
BSP-512-01-00

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

QuickVue - 30014613339724

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

QuickVue - 30014613339687

QuickVue At-Home OTC COVID-19 Test
QUIDEL CORPORATION
20399
In Commercial Distribution

  • 30014613339687 ()
20399

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

QuickVue - 30014613339670

QuickVue At-Home OTC COVID-19 Test
QUIDEL CORPORATION
20398
In Commercial Distribution

  • 30014613339670 ()
20398

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

Genabio - 06942468181683

Genabio COVID-19 Rapid Self-Test Kit
Core Technology Co.,Ltd.
BP291-5
In Commercial Distribution

  • 06942468183007 ()
  • 06942468181683 ()
  • 16942468181680 ()


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