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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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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
Pre-aliquoted 96-well PCR plate. Each well contains a 20µL lyophilized triplex reaction. Assay only.
Biomeme, Inc.
1
In Commercial Distribution

  • 10810096640090 ()
  • 00810096640093 ()
3000634

  • Nucleic acid amplification mastermix reagent IVD
Pre-aliquoted 3-well PCR strips. Each well contains a 20µL lyophilized triplex reaction. Assay only.
Biomeme, Inc.
1
In Commercial Distribution

  • 10810096640052 ()
  • 00810096640055 ()
3000633

  • Nucleic acid amplification mastermix reagent IVD
A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
Alere Scarborough, Inc.
195-241
In Commercial Distribution

  • 00811877011798 ()


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