Medical Devices

In Vitro Diagnostics

In vitro diagnostics are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person’s overall health to help cure, treat, or prevent diseases.

In vitro diagnostics may also be used in precision medicine to identify patients who are likely to benefit from specific treatments or therapies. These in vitro diagnostics can include next generation sequencing tests, which scan a person’s DNA to detect genomic variations.

Some tests are used in laboratory or other health professional settings and other tests are for consumers to use at home.

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Contact FDA

301-796-5450

CDRH-Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
10903 New Hampshire Avenue
WO66-5521
Silver Spring, MD 20993

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Page Last Updated: 12/03/2018
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