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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 - 00811877011736

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
Alere Scarborough, Inc.
195-280
In Commercial Distribution

  • 00811877011736 ()


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

BinaxNOW COVID-19 Antigen Self Test - 00811877011712

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
Alere Scarborough, Inc.
195-269
In Commercial Distribution

  • 00811877011712 ()


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

BinaxNOW COVID-19 Antigen Self Test - 00811877011705

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
Alere Scarborough, Inc.
195-268
In Commercial Distribution

  • 00811877011705 ()


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

BinaxNOW COVID-19 Antigen Self Test - 00811877011699

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
Alere Scarborough, Inc.
195-267
In Commercial Distribution

  • 00811877011699 ()


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

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 Reagent Accessory Kit - 00811877011576

Reagent Accessory Pack intended for use only with BinaxNOW™ COVID-19 product.
Alere Scarborough, Inc.
195-090
In Commercial Distribution

  • 00811877011576 ()


  • SARS-CoV-2 antigen IVD, reagent

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
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