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Over 300 COVID-19 Tests and Collection Kits Authorized by the FDA in 2020


Recently, the FDA revealed traces of their fiercest battle against the COVID-19 pandemic last year.

"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



This infographic provides a visualization of data about the coronavirus (COVID-19) diagnostic tests authorized by the FDA in 2020. According to data, the FDA authorized over 300 tests and collection kits, including 235 molecular, 63 antibody, 11 antigen test.


"In a challenging year, we’ve seen the FDA respond with diligence and effectiveness. This kind of work ethic and dedication to the FDA mission – effective, efficient, and focused on protecting and promoting public health on behalf of the American patients and consumers we serve – is evident across the FDA. I commend the entire FDA team for working so hard on behalf of the American public. I know this same focus and diligence will lead us into a successful and productive 2021." Stephen M. Hahn, M.D., Commissioner of Food and Drugs








SOURCE: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-tests-and-collection-kits-authorized-fda-2020-infographic