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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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CARTON-RDB1V10-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Test (1 Test/Box) - 30810172700094

No Description
WatMIND USA
CARTON-RDB1V10-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Test (1 Test/Box)
In Commercial Distribution

  • 30810172700094 ()


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

CARTON-RDB2V6-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Test (2 Tests/Box) - 30810172700087

No Description
WatMIND USA
CARTON-RDB2V6-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Test (2 Tests/Box)
In Commercial Distribution

  • 30810172700087 ()


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

WELLlife™ - 00816862024500

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

CorDx Tyfast - 00850042559567

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 - 00850042559550

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 - 00850042559536

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 - 00850042559529

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

SLM Inlay Co Cr - 06975031821235

No Description
Beijing Yingguan Dental Technology Co., Ltd.
/
In Commercial Distribution

  • 06975031821235 ()


  • Dental casting non-noble alloy

CAD/CAM Inlay Resin - 06975031820979

No Description
Beijing Yingguan Dental Technology Co., Ltd.
/
In Commercial Distribution

  • 06975031820979 ()


  • Dental casting non-noble alloy

CAD/CAM Inlay Glass Ceramic - 06975031820962

No Description
Beijing Yingguan Dental Technology Co., Ltd.
/
In Commercial Distribution

  • 06975031820962 ()


  • Dental casting non-noble alloy
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