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U.S. Department of Health and Human Services

Medical Devices

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In Vitro Diagnostics

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In vitro diagnostics are tests that can detect diseases, conditions, or infections. Some tests are used in laboratory or other health professional settings and other tests are for consumers to use at home.


Information for Health Professionals


Authorizations (EUA)


Contact FDA

CDRH-Office of In Vitro Diagnostics and Radiological Health

Center for Devices and Radiological Health

10903 New Hampshire Avenue


Silver Spring, MD 20993