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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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OSOM COVID-19 Antigen Rapid Test
SEKISUI DIAGNOSTICS, LLC
1066-40
In Commercial Distribution

  • 00742860000027 ()
  • 10742860000024 ()
1066-40

  • 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
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
ACT21002-4
In Commercial Distribution

  • 10850042559564 ()
  • 00850042559567 ()
  • 00850042559543 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
ACT21002-2
In Commercial Distribution

  • 10850042559557 ()
  • 00850042559550 ()
  • 00850042559543 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
ACT21002-5
In Commercial Distribution

  • 10850042559533 ()
  • 00850042559536 ()
  • 00850042559543 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
ACT21002-1
In Commercial Distribution

  • 00850042559529 ()
  • 10850042559526 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
WELLlife™ COVID-19/Influenza A&B Home Test Cassette,2 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0001
In Commercial Distribution

  • 10816862024507 ()
  • 00816862024500 ()
  • 00816862024579 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
No Description
INBIOS INTERNATIONAL, INC
COVG-RE
In Commercial Distribution

  • B379COVGRE1 ()


  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical
No Description
Beijing Yingguan Dental Technology Co., Ltd.
/
In Commercial Distribution

  • 06975031821235 ()


  • Dental casting non-noble alloy
No Description
Beijing Yingguan Dental Technology Co., Ltd.
/
In Commercial Distribution

  • 06975031820979 ()


  • Dental casting non-noble alloy
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