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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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Tubes filled with 3mL aliquots of Biomemes DNA/RNA Preservation buffer for sample collection, storage, and preservation at room temperature. Pack of 100 pre-filled tubes.
Biomeme, Inc.
1
In Commercial Distribution

  • 10810096640106 ()
  • 00810096640109 ()
3000577

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
First Aid Kit in a Plastic Cabinet with SmartCompliance boxes. Kit designed for food service industry, contains first aid supplies to help treat minor injuries.
Acme United Corporation
91094
In Commercial Distribution

  • 00092265910941 ()
91094

  • First aid kit, medicated
This emergency first aid kit is packed full of necessary first aid supplies to treat a variety of issues to include dehydration, scrapes, cuts, and over-the-counter medications for multiple ailments. The Adventurer Kit also includes an emergency survival blanket, elastic bandage wrap, and an irrigation syringe to prepare you for your next exciting adventure!
Altitude Technologies Inc.
01424RD
In Commercial Distribution

  • 00850018201407 ()


  • First aid kit, medicated
No Description
Modern Dental Laboratory (DG) Co., Ltd.
314
In Commercial Distribution

  • 06972677873154 ()
  • 06972677873147 ()


  • Dental casting noble alloy
  • Custom-made dental crown, metal
  • Gold dental inlay
  • Custom-made dental crown, ceramic
  • Dental bridge, ceramic
  • Ceramic dental inlay
  • Dental veneer, professional
  • Removable dental occlusal splint, preformed
  • Orthodontic appliance system, bonded
  • Orthodontic retainer
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-1
In Commercial Distribution

  • 08800076700734 ()
COVAGHT2-U-01

  • 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-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
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-2
In Commercial Distribution

  • 08800076700741 ()
  • 08800076700222 ()
COVAGHT2-U-02

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit for the qualitative detection of IgM antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19).
Gold Standard Diagnostics Corporation
GSD01-1030
Not in Commercial Distribution

  • B350GSD0110300 ()
GSD01-1030

  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit for the qualitative detection of IgA antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19).
Gold Standard Diagnostics Corporation
GSD01-1029
Not in Commercial Distribution

  • B350GSD0110290 ()
GSD01-1029

  • SARS-CoV-2 immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
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