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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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Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
Xiamen Boson Biotech Co., Ltd.
1N40C5-8-US
In Commercial Distribution

  • 06921963715258 ()
  • 06921963712929 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
Xiamen Boson Biotech Co., Ltd.
1N40C5-20-US
In Commercial Distribution

  • 06921963715258 ()
  • 06921963712523 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
Xiamen Boson Biotech Co., Ltd.
1N40C5-5-US
In Commercial Distribution

  • 06921963715258 ()
  • 06921963712516 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
Xiamen Boson Biotech Co., Ltd.
1N40C5-2-US
In Commercial Distribution

  • 06921963712509 ()
  • 06921963715258 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
Xiamen Boson Biotech Co., Ltd.
1N40C5-1-US
In Commercial Distribution

  • 06921963712493 ()
  • 16921963712490 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
First Aid kit containing Drugs OTC and Medical Devices class I: Triple Antibiotic, First Aid Burn cream, Triangular Bandage, Gauze Pads, Adhesive Tape, Gauze Compress, Adhesive Bandage, Nitrile gloves, Antiseptic Towelettes, Elastic Bandage, Scissor bandage, Tweezer, Cold Pack, Micro shield, Wipe Sanitize, Antiseptic wipes, Face mask with shield.
North Safety de Mexicali, S. de R. L. de C.V.
SF00003260
In Commercial Distribution

  • 00883940161068 ()


  • First aid kit, medicated
First Aid Kit containing Drugs OTC and Medical Devices class I: Woven, Adhesive tape, Nitrile Gloves, Antiseptic Towelettes, Survival Blanket, Scissor bandage, Splinter Forceps, Bandage compress, CPR Mask, Triangular bandage, Gauze pads.
North Safety de Mexicali, S. de R. L. de C.V.
SF00001996
In Commercial Distribution

  • 00883940051529 ()


  • First aid kit, medicated
Sports FAK Basketball w/ Clip
Adventure Ready Brands
1
In Commercial Distribution

  • 00707708711114 ()
0128-1111

  • First aid kit, medicated
Cabela's Guide II
Adventure Ready Brands
1
In Commercial Distribution

  • 00707708602023 ()
2099-0202

  • First aid kit, medicated
Sportsman 200
Adventure Ready Brands
1
In Commercial Distribution

  • 00707708302008 ()
0105-0200

  • First aid kit, medicated
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