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FDA Authorizes New COVID Tests

FDA Authorizes New COVID Tests

The FDA authorized the following new diagnostic tests:

  • Lucira COVID-19 and Flu Test is a single use molecular test intended for detection of both the SARS-CoV-2 and influenza (A or B) viruses. It can be used in a point-of-care setting for persons age two years and older.
  • Fastep COVID-19 Antigen Home Test, manufactured by azure Biotech Inc., can be used as a serial test for people with or without symptoms and provides results in 15 minutes.
  • CorDx COVID-19 Antigen Test shows results in ten minutes and can be used as a serial test for people with or without symptoms.