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

"Our Center for Devices and Radiological Health (CDRH) has made enormous contributions to the COVID-19 response. To date, the FDA has authorized 309 tests and sample collection devices. This includes a wide variety of tests, including 235 molecular tests and sample collection devices, 63 antibody tests, and 11 antigen tests, with tests that can be used in laboratories, in doctors' offices and other point-of-care settings, and at home." Stephen M. Hahn, M.D., Commissioner of Food and Drugs

2020 at FDA: A Year of Unparalleled Commitment to Public Health

This infographic provides a visualization of data about the coronavirus (COVID-19) diagnostic tests authorized by the FDA in 2020.

Text Version of 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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