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  6. COVID-19 Tests and Collection Kits Authorized by the FDA: Infographic
  1. Coronavirus (COVID-19) and Medical Devices

COVID-19 Tests and Collection Kits Authorized by the FDA: Infographic

This infographic provides a visualization of data about the coronavirus (COVID-19) diagnostic tests authorized by the FDA.

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COVID-19 Tests and Collection Kids Authorized by the FDA

Text Version of Infographic

COVID-19 Tests and Collection Kits Authorized by the FDA

The FDA is committed to helping ensure the public has access to a wide variety of test options for COVID-19. Since the start of the pandemic, we authorized over 400 tests and collection kits, including:

  • 235 molecular
  • 88 antibody
  • 34 antigen tests

Such as:

  • 63 home collection: Tests and collection kits where samples are collected at home and sent to a lab for processing
  • 32 pooling: Tests that process samples from multiple people at one time
  • 55 point-of-care: Tests and rapidly return a result at your doctor's office or other health care setting
  • 19 multi-analyte: Tests that detect the virus that causes COVID-19 and other viruses like flu
  • 13 at-home: Tests performed at home with a self-collected sample

Current as of 9/10/21

For more information, please visit fda.gov/medical-devices

Infographic for 2020*

The FDA released an initial version of this infographic for 2020.

Text version of the 2020 infographic:

COVID-19 Tests and Collection Kits Authorized by the FDA in 2020

The FDA is committed to helping ensure the public has access to a wide variety of test options for COVID-19. Since the start of the pandemic, we authorized over 300 tests and collection kits, including:

  • 235 molecular
  • 63 antibody
  • 11 antigen tests

Such as:

  • 38 home collection: Tests and collection kits where samples are collected at home and sent to a lab for processing
  • 18 pooling: Tests that process samples from multiple people at one time
  • 17 point-of-care: Tests and rapidly return a result at your doctor's office or other health care setting
  • 11 multi-analyte: Tests that detect the virus that causes COVID-19 and other viruses like flu
  • 3 at-home: Tests performed at home with a self-collected sample

*Current as of 12/28/2020

For more information, please visit fda.gov/medical-devices

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