SEARCH RESULTS FOR: 得克萨斯A(9271 results)

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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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Boson - Rapid SARS-CoV-2 Antigen Test Card - 1 Tests/Kit - 06921963712493

Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
Xiamen Boson Biotech Co., Ltd.
1N40C5-1-US
In Commercial Distribution

  • 06921963712493 ()
  • 16921963712490 ()


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

Bio-Self COVID-19 Antigen Home Test - 00860013635121

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

Bio-Self COVID-19 Antigen Home Test - 00860013635114

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

Bio-Self COVID-19 Antigen Home Test - 00860013635107

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

Genabio COVID-19 Rapid Self-Test Kit - 00860008954879

No Description
Genabio Diagnostics Inc.
RA9-E00302
In Commercial Distribution

  • 00860008954862 ()
  • 00860008954879 ()


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

Genabio COVID-19 Rapid Self-Test Kit - 00860008954862

No Description
Genabio Diagnostics Inc.
RA9-E00301
In Commercial Distribution

  • 00860008954862 ()


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

Genabio COVID-19 Rapid Self-Test Kit - 00860008954831

No Description
Genabio Diagnostics Inc.
RA9-E00305
In Commercial Distribution

  • 00860008954862 ()
  • 00860008954831 ()


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

Genabio COVID-19 Rapid Self-Test Kit - 00860008954824

No Description
Genabio Diagnostics Inc.
RA9-E00325
In Commercial Distribution

  • 00860008954862 ()
  • 00860008954824 ()


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

iHealth - 00850044118458

No Description
IHEALTH LAB INC.
ICF-3000
In Commercial Distribution

  • 10850044118455 ()
  • 00850044118458 ()
  • 20850044118452 ()
  • 30850044118459 ()


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

iHealth - 00850044118434

No Description
IHEALTH LAB INC.
ICF-3000
In Commercial Distribution

  • 10850044118431 ()
  • 00850044118434 ()
  • 20850044118438 ()
  • 30850044118435 ()


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