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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An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2. Nano-Check™ COVID-19 Antigen Test is intended for use by medical professionals or operators who are proficient in performing tests.
NANO-DITECH CORPORATION
MD-8147
In Commercial Distribution

  • 10895160002783 ()
  • 00895160002786 ()
  • 20895160002780 ()
MD-8147-20T

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
A in vitro diagnostic test for the qualitative detection of IgG/IgM antibodies against SARS-CoV-2 virus using human blood/serum/plasma samples.
NANO-DITECH CORPORATION
MD8145
In Commercial Distribution

  • 10895160002660 ()
  • 00895160002663 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
An in vitro diagnostic test for the detection of anti-Dengue IgM and/or IgG in human whole blood of dengue infected patient from acute to convalescent stage.
NANO-DITECH CORPORATION
MD8144
In Commercial Distribution

  • 00895160002489 ()
  • 10895160002486 ()
MD8144

  • Dengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, rapid ICT, clinical
COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma)
BTNX Inc
COV-13C25
In Commercial Distribution

  • 10722066005115 ()
  • 00722066005118 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
WELLlife™ COVID-19/Influenza A&B Test Cassette, 25 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0002-S
In Commercial Distribution

  • 10816862026860 ()
  • 00816862026863 ()
  • 00816862026856 ()


  • Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical
WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 2 Tests per Kitbox with Holder; SD
WONDFO USA CO., LTD.
WV01P0001-2S
In Commercial Distribution

  • 10816862026150 ()
  • 00816862026153 ()
  • 00816862026146 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 25 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0001-25
In Commercial Distribution

  • 10816862024729 ()
  • 00816862024722 ()
  • 00816862024715 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 10 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0001-10
In Commercial Distribution

  • 10816862024705 ()
  • 00816862024708 ()
  • 00816862024692 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 5 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0001-5
In Commercial Distribution

  • 10816862024682 ()
  • 00816862024685 ()
  • 00816862024678 ()


  • 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.
WV01P0001-2
In Commercial Distribution

  • 10816862024668 ()
  • 00816862024661 ()
  • 00816862024654 ()


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