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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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WELLlife™ - 00816862024722

WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 25 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0001-25
In Commercial Distribution

  • 10816862024729 ()
  • 00816862024722 ()
  • 00816862024715 ()


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

WELLlife™ - 00816862024708

WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 10 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0001-10
In Commercial Distribution

  • 10816862024705 ()
  • 00816862024708 ()
  • 00816862024692 ()


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

WELLlife™ - 00816862024685

WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 5 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0001-5
In Commercial Distribution

  • 10816862024682 ()
  • 00816862024685 ()
  • 00816862024678 ()


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

WELLlife™ - 00816862024661

WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 2 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0001-2
In Commercial Distribution

  • 10816862024668 ()
  • 00816862024661 ()
  • 00816862024654 ()


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

WELLlife™ - 00816862024630

WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 1 Test per Kitbox
WONDFO USA CO., LTD.
WV01P0001-1
In Commercial Distribution

  • 10816862024637 ()
  • 00816862024630 ()


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

SCoV-2 Ag Detect™ Rapid Self-Test - B379CAGS21

No Description
INBIOS INTERNATIONAL, INC
CAGS-2
In Commercial Distribution

  • B379CAGS21 ()


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

Advin COVID-19 Antigen Test @Home - B115ABCASS5CANAO1

No Description
ADVIN BIOTECH, INC.
ABCass(5)-CAN-AO
In Commercial Distribution

  • B115ABCASS5CANAO1 ()
  • B115ABCASS5CANAO0 ()


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

Advin COVID-19 Antigen Test @Home - B115ABCASS2CANAO1

No Description
ADVIN BIOTECH, INC.
ABCass(2)-CAN-AO
In Commercial Distribution

  • B115ABCASS2CANAO1 ()
  • B115ABCASS2CANAO0 ()


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

Advin COVID-19 Antigen Test @Home - B115ABCASS1CANAO1

No Description
ADVIN BIOTECH, INC.
ABCass(1)-CAN-AO
In Commercial Distribution

  • B115ABCASS1CANAO1 ()
  • B115ABCASS1CANAO2 ()


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

Status™ COVID-19 Antigen Rapid Test for Home Use - 10743816001638

Status™ COVID-19 Antigen Rapid Test for Home Use, 2 Test Kit
PRINCETON BIOMEDITECH CORPORATION
BSP-512-02-00
In Commercial Distribution

  • 10743816001638 ()
BSP-512-02-00

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