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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 - 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

BinaxNOW COVID-19 Ag Card Home Test - 00811877011330

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens
Alere Scarborough, Inc.
195-100
In Commercial Distribution

  • 00811877011330 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Bio-Self COVID-19 Antigen Home Test - 00197644563371

COVID-19 antigen self home test in vitro diagnostic use only (1 Test Kit/Box)
BIOTEKE USA, LLC
BTK-H2201
In Commercial Distribution

  • 00197644563371 ()


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

Bio-Self COVID-19 Antigen Home Test - 00197644380435

COVID-19 antigen self home test in vitro diagnostic use only (2 Test Kits/Box)
BIOTEKE USA, LLC
BTK-H2202
In Commercial Distribution

  • 00197644380435 ()


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

Bio-Self COVID-19 Antigen Home Test - 00197644204359

COVID-19 antigen self home test in vitro diagnostic use only (5 Test Kits/Box)
BIOTEKE USA, LLC
BTK-H2205
In Commercial Distribution

  • 00197644204359 ()


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

BinaxNOW COVID-19 Ag Card Home Test - 10811877011337

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens
Alere Scarborough, Inc.
195-200
In Commercial Distribution

  • 10811877011337 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Bio-Self COVID-19 Antigen Home Test - 00860013635107

COVID-19 antigen self home test in vitro diagnostic use only (1 Test Kit/Box)
BIOTEKE USA, LLC
BTK-H2201
In Commercial Distribution



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

Bio-Self COVID-19 Antigen Home Test - 00860013635121

COVID-19 antigen self home test in vitro diagnostic use only (5 Test Kits/Box)
BIOTEKE USA, LLC
BTK-H2205
In Commercial Distribution



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