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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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Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 anterior nasal (AN) swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset. For use under an emergency use authorization (EUA) only.
Genbody Inc.
COVAG025-NU
In Commercial Distribution

  • 08800076700499 ()
  • 08800076700482 ()
COVAG025-NU

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

  • B379COVAGRC1 ()


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

  • 00810172700086 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
No Description
WatMIND USA
Speedy Swab Rapid COVID-19 & FLU A+B (4 Tests/Box)
In Commercial Distribution

  • 00810172700079 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
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
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
WELLlife™ COVID-19/Influenza A&B Test Cassette, 25 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0002
In Commercial Distribution

  • 10816862024583 ()
  • 00816862024586 ()
  • 00816862024593 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
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
QuickVue® SARS Antigen Test
QUIDEL CORPORATION
20387
In Commercial Distribution

  • 30014613339373 ()
20387

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