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

  • 00810143620184 ()
  • 81014362018400 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
No Description
WatMIND USA
CARTON-1V500-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (1 Test/Box)
In Commercial Distribution

  • 50810172700098 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
No Description
WatMIND USA
CARTON-2V300-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box)
In Commercial Distribution

  • 50810172700081 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
No Description
Bioteke Corporation (Wuxi) Co., Ltd.
BTK-H2205
In Commercial Distribution

  • 86974541564409 ()
  • 06974541564403 ()
BTK-H2205

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
No Description
Bioteke Corporation (Wuxi) Co., Ltd.
BTK-H2201
In Commercial Distribution

  • 06974541564397 ()
BTK-H2201

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
No Description
Bioteke Corporation (Wuxi) Co., Ltd.
BTK-H2202
In Commercial Distribution

  • 06974541564380 ()
  • 86974541564386 ()
BTK-H2202

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
No Description
INBIOS INTERNATIONAL, INC
COVAG-RC
In Commercial Distribution

  • B379COVAGRC1 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
No Description
INBIOS INTERNATIONAL, INC
CAGS-2
In Commercial Distribution

  • B379CAGS21 ()


  • 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
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