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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CorDx COVID-19 Ag Test
CORETESTS, INC.
CO291-5
In Commercial Distribution

  • 10850042559137 ()
  • 00850042559130 ()
  • 00850042559116 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx COVID-19 Ag Test
CORETESTS, INC.
CO291-2
In Commercial Distribution

  • 00850042559079 ()
  • 10850042559076 ()
  • 00850042559109 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test POC
CORETESTS, INC.
ACT21001-25
In Commercial Distribution

  • 00850042559635 ()
  • 10850042559632 ()
  • 00850042559512 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
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 COVID-19 Ag Test
CORETESTS, INC.
CO291-10
In Commercial Distribution

  • 10850042559144 ()
  • 00850042559147 ()
  • 00850042559116 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx COVID-19 Ag Test
CORETESTS, INC.
CO291-2
In Commercial Distribution

  • 10850042559120 ()
  • 00850042559123 ()
  • 00850042559116 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx COVID-19 Ag Test
CORETESTS, INC.
CO291-10
In Commercial Distribution

  • 00850042559093 ()
  • 10850042559090 ()
  • 00850042559109 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx COVID-19 Ag Test
CORETESTS, INC.
CO291-5
In Commercial Distribution

  • 00850042559086 ()
  • 10850042559083 ()
  • 00850042559109 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Test Cassettes (25), 2.5mL Buffer Bottles (2), Droppers (25)
Acon Laboratories, Inc.
L031-11711
In Commercial Distribution

  • 20682607200973 ()
  • 00682607200979 ()
  • 00682607002269 ()
200979

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Genabio COVID-19 Rapid Self-Test Kit
Core Technology Co.,Ltd.
BP291-5
In Commercial Distribution

  • 06942468183007 ()
  • 06942468181683 ()
  • 16942468181680 ()


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