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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COVID-19 antigen self home test in vitro diagnostic use only (5 Test Kits/Box)
BIOTEKE USA, LLC
BTK-H2205
In Commercial Distribution



  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
COVID-19 antigen self home test in vitro diagnostic use only (2 Test Kits/Box)
BIOTEKE USA, LLC
BTK-H2202
In Commercial Distribution



  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
COVID-19 antigen self home test in vitro diagnostic use only (1 Test Kit/Box)
BIOTEKE USA, LLC
BTK-H2201
In Commercial Distribution



  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
No Description
HF ACQUISITION CO. LLC
1018360
Not in Commercial Distribution

1018360

  • First aid kit, medicated
No Description
HF ACQUISITION CO. LLC
1008700
Not in Commercial Distribution

1008700

  • First aid kit, medicated
No Description
HF ACQUISITION CO. LLC
1008670
In Commercial Distribution

1008670

  • First aid kit, medicated
No Description
HF ACQUISITION CO. LLC
1008690
Not in Commercial Distribution

1008690

  • First aid kit, medicated
No Description
HF ACQUISITION CO. LLC
1008680
Not in Commercial Distribution

1008680

  • First aid kit, medicated
No Description
HF ACQUISITION CO. LLC
1010830
Not in Commercial Distribution

1010830

  • First aid kit, medicated
No Description
HF ACQUISITION CO. LLC
1009580
Not in Commercial Distribution

1009580

  • First aid kit, medicated
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