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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No Description
Shenzhen Yurucheng Dental Materials Co., Ltd.
ML-BL2-3D
In Commercial Distribution

  • 06942053528664 ()
3DPlus 95×10mm

  • Dental appliance fabrication material, ceramic
No Description
Shenzhen Yurucheng Dental Materials Co., Ltd.
ML-C3-3D
In Commercial Distribution

  • 06942053526424 ()
3DPlus 95×12mm

  • Dental appliance fabrication material, ceramic
No Description
Shenzhen Yurucheng Dental Materials Co., Ltd.
ML-C1-3D
In Commercial Distribution

  • 06942053526042 ()
3DPlus 89×71×20mm

  • Dental appliance fabrication material, ceramic
The QuickProfile Covid-19/Influenza A&B Antigen Combo Test is a lateral flow immunoassay intended for the qualitative and differential detection of nucleocapsid protein from SARS-CoV-2, influenza A and influenza B proteins using self-collected anterior nares nasal swab samples from individuals aged 14 years or older. This test is authorized for non-prescription home use with self-collected anterior nares nasal swab samples from individuals aged 14 years or older with symptoms of SARS-CoV-2, influenza A and influenza B within the first 6 days of symptom onset. This test is also authorized for non-prescription home use with adult-collected anterior nasal swab samples from individuals aged 2 years or older with symptoms of SARS-CoV-2, influenza A and influenza B within the first 6 days of symptom onset.
LUMIQUICK DIAGNOSTICS, INC.
71118-1T
In Commercial Distribution

  • 00855636003808 ()
  • 00855636003815 ()
  • 00855636003822 ()
  • 00855636003839 ()
  • 00855636003846 ()
  • 00855636003853 ()
71118-1T

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
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
Special Tactics IFAK Kit
Nar Medical Depot, LLC
TRM119015
In Commercial Distribution

  • 00860009615519 ()
TRM119015

  • First aid kit, medicated
SOURCING FA KIT
Innovation Specialties
FA SOURCE KIT
In Commercial Distribution

  • 00860009239654 ()


  • First aid kit, medicated
No Description
Genabio Diagnostics Inc.
RA9-E00302
In Commercial Distribution

  • 00860008954862 ()
  • 00860008954879 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
No Description
Genabio Diagnostics Inc.
RA9-E00301
In Commercial Distribution

  • 00860008954862 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
No Description
Genabio Diagnostics Inc.
RA9-E00305
In Commercial Distribution

  • 00860008954862 ()
  • 00860008954831 ()


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