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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™ 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
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™ 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™ 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
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 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™ 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
No Description
MONOBIND, INC.
12525-300
In Commercial Distribution

  • 00816870024875 ()

  • Width: 7.75 Inch
12525-300B

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Accula™ SARS-Cov-2 Test performed on the Accula™ Dock or the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of the coronavirus SARS-CoV-2 viral RNA. The Accula SARS-CoV-2 Test uses a throat swab and nasal swab specimen collected from patients who meet CDC SARS-CoV-2 clinical criteria and in conjunction with epidemiological criteria to aid in the diagnosis of SARS-CoV-2 infection.
MESA BIOTECH, INC.
COV4100
In Commercial Distribution

  • B540COV41000 ()
COV4100

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
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