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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UNICO GLOBAL INC
FM-EU2001
In Commercial Distribution

  • 08809783490525 ()
  • 08809783490624 ()


  • Public face mask, single-use
An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2.
NANO-DITECH CORPORATION
MD-8147
In Commercial Distribution

  • 10895160002868 ()
  • 00895160002861 ()
MD-8147 2T

  • SARS-CoV-2 antigen 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
An in vitro diagnostic, a time resolved fluorescence lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2.
NANO-DITECH CORPORATION
TF-8150
In Commercial Distribution

  • 10895160002790 ()
  • 00895160002793 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2. Nano-Checkā„¢ 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
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-1
In Commercial Distribution

  • 08800076700772 ()
  • 08800076700789 ()
COVAG025-NU-1

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. For use under an emergency use authorization (EUA) only.
Genbody Inc.
COVAGHT2-U-5
In Commercial Distribution

  • 08800076700758 ()
  • 08800076700727 ()
COVAGHT2-U-05

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. For use under an emergency use authorization (EUA) only.
Genbody Inc.
COVAGHT2-U-25
In Commercial Distribution

  • 08800076700765 ()
  • 08800076700598 ()
COVAGHT2-U-25

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