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U.S. Department of Health and Human Services

Medical Devices

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Find All FDA-Approved Home and Lab Tests

You can find information about each home or lab test that FDA has approved or cleared by searching FDA’s Database of In Vitro Diagnostic (IVD) Tests.

To use this database,

  1. enter a search term (for example the type of test, name, company, or other key word) in the blank space
  2. click on “Search”
  3. review the listing of products that match your search term
  4. select any products for additional information (including Decision Summaries)

Link to Database of In Vitro Diagnostic (IVD) Tests