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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 - 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

WELLlife™ - 00816862024722

WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 25 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0001-25
In Commercial Distribution

  • 10816862024729 ()
  • 00816862024722 ()
  • 00816862024715 ()


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

WELLlife™ - 00816862024708

WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 10 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0001-10
In Commercial Distribution

  • 10816862024705 ()
  • 00816862024708 ()
  • 00816862024692 ()


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

WELLlife™ - 00816862024685

WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 5 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0001-5
In Commercial Distribution

  • 10816862024682 ()
  • 00816862024685 ()
  • 00816862024678 ()


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

WELLlife™ - 00816862024661

WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 2 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0001-2
In Commercial Distribution

  • 10816862024668 ()
  • 00816862024661 ()
  • 00816862024654 ()


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