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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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-25
In Commercial Distribution

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

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
D&C PACK
AMERICAN CONTRACT SYSTEMS, INC.
HWDC06L
In Commercial Distribution

  • 00191072203533 ()


  • General surgical procedure kit, non-medicated, single-use
D & C PACK
AMERICAN CONTRACT SYSTEMS, INC.
LLDC40K
In Commercial Distribution

  • 00191072200310 ()


  • General surgical procedure kit, non-medicated, single-use
D & C RCRH
AMERICAN CONTRACT SYSTEMS, INC.
RCDC35A
In Commercial Distribution

  • 00191072204820 ()


  • General surgical procedure kit, non-medicated, single-use
D AND C PACK
AMERICAN CONTRACT SYSTEMS, INC.
IHDC30Q
In Commercial Distribution

  • 00191072204738 ()


  • General surgical procedure kit, non-medicated, single-use
D&C HYSTEROSCOPY
AMERICAN CONTRACT SYSTEMS, INC.
GBDC45D
In Commercial Distribution

  • 00191072204431 ()


  • General surgical procedure kit, non-medicated, single-use
D&C PACK
AMERICAN CONTRACT SYSTEMS, INC.
THDC43D
In Commercial Distribution

  • 00191072196583 ()


  • General surgical procedure kit, non-medicated, single-use
OPERATIVE HYSTEROSCOPY PK ESC
AMERICAN CONTRACT SYSTEMS, INC.
EVHY68A
In Commercial Distribution

  • 00191072194770 ()


  • General surgical procedure kit, non-medicated, single-use
D&C PACK
AMERICAN CONTRACT SYSTEMS, INC.
HGDC23E
In Commercial Distribution

  • 00191072193599 ()


  • General surgical procedure kit, non-medicated, single-use
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