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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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BinaxNOW COVID-19 Antigen Self Test - 00811877011682

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
Alere Scarborough, Inc.
195-266
In Commercial Distribution

  • 00811877011682 ()


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

BinaxNOW COVID-19 Antigen Self Test - 00811877011675

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
Alere Scarborough, Inc.
195-265
In Commercial Distribution

  • 00811877011675 ()


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

BinaxNOW COVID-19 Antigen Self Test - 00811877011521

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
Alere Scarborough, Inc.
195-264
In Commercial Distribution

  • 00811877011521 ()


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

BinaxNOW COVID-19 Antigen Self Test - 00811877011514

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
Alere Scarborough, Inc.
195-270
In Commercial Distribution

  • 00811877011514 ()


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

BinaxNOW COVID-19 Antigen Self Test - 00811877011507

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
Alere Scarborough, Inc.
195-240
In Commercial Distribution

  • 00811877011507 ()


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

BinaxNOW COVID-19 Antigen Self Test - 00811877011460

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
Alere Scarborough, Inc.
195-263
In Commercial Distribution

  • 00811877011460 ()


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

BinaxNOW COVID-19 Antigen Self Test - 00811877011453

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
Alere Scarborough, Inc.
195-262
In Commercial Distribution

  • 00811877011453 ()


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

BinaxNOW COVID-19 Antigen Self Test - 00811877011446

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
Alere Scarborough, Inc.
195-261
In Commercial Distribution

  • 00811877011446 ()


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

BinaxNOW COVID-19 Antigen Self Test - 00811877011415

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
Alere Scarborough, Inc.
195-260
In Commercial Distribution

  • 00811877011415 ()


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

Genabio COVID-19 Rapid Self-Test Kit - 00810143620184

No Description
Genabio Diagnostics Inc.
N/A
In Commercial Distribution

  • 00810143620184 ()
  • 81014362018400 ()


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