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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WELLlife™ COVID-19/Influenza A&B Test Cassette, 25 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0002
In Commercial Distribution

  • 10816862024583 ()
  • 00816862024586 ()
  • 00816862024593 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
WELLlife™ COVID-19/Influenza A&B Home Test Cassette,2 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0001
In Commercial Distribution

  • 10816862024507 ()
  • 00816862024500 ()
  • 00816862024579 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
WELLlife™ COVID-19/Influenza A&B Test Cassette, 25 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0002-S
In Commercial Distribution

  • 10816862026860 ()
  • 00816862026863 ()
  • 00816862026856 ()


  • Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical
WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 2 Tests per Kitbox with Holder; SD
WONDFO USA CO., LTD.
WV01P0001-2S
In Commercial Distribution

  • 10816862026150 ()
  • 00816862026153 ()
  • 00816862026146 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Face mask is made of fabric material, either non-woven or woven
PHU TUONG GARMENT COMPANY LIMITED
PT05
In Commercial Distribution

  • 28938533047055 ()
  • 18938533047058 ()


  • Public face mask, single-use
No Description
Foshan GoodFeeling Hygiene Material Tec Co., Ltd.
GFYC01
In Commercial Distribution

  • 06973078400147 ()
  • 06973078400161 ()


  • Surgical/medical face mask, single-use
No Description
Neumodx Molecular, Inc.
300800
Not in Commercial Distribution

  • 00814278021267 ()
  • 10814278021264 ()
300800

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Yiwu Ori-Power Medtech Co.,Ltd.
OP3009161
In Commercial Distribution

  • 06974686052148 ()
  • 06974686059123 ()


  • First aid kit, medicated
No Description
Yiwu Ori-Power Medtech Co.,Ltd.
OP3000394
In Commercial Distribution

  • 06974686058171 ()
  • 06974686052148 ()


  • First aid kit, medicated
No Description
Yiwu Ori-Power Medtech Co.,Ltd.
OP3000125
In Commercial Distribution

  • 06974686052148 ()
  • 06974686057273 ()


  • First aid kit, medicated
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