At-home tests can be sold as test strips, devices or kits with laboratory processing. FDA status is tied to a specific product and intended use. Check the exact name and maker in FDA's IVD database, read the labeling and distinguish a test's regulatory status from the certification of a laboratory. Ask a doctor to discuss results or product choice.
At-home tests can be sold as a device for consumer use or as a collection kit sent to a laboratory. The product name, intended use and processing details determine which records are relevant.
Label and database checklist
| Check | What to look for |
|---|---|
| Exact product | Brand, model or test name on the package |
| Maker | Company name shown on the label and FDA record |
| Intended use | The test type, sample and purpose described in the labeling |
| FDA record | Whether FDA lists the exact product as approved or cleared |
| Sample and processing | Home-read result, mailed sample, or laboratory processing |
| Laboratory | Name and certification information for a lab-processed test |
The FDA says its IVD database can be searched for home or lab tests that the agency has approved or cleared. Search by the exact product name where possible, then review the product’s record and intended use. Similar names or a broad test category do not establish that a particular kit has the same status.
Step-by-step lookup
- Photograph or write down the full product name and manufacturer from the label.
- Note the sample type and whether the result is read at home or processed by a lab.
- Open the FDA’s approved and cleared home and lab test search.
- Search by product name, test type or company, then open the matching record.
- Compare the record with the product label, including the intended use and sample type.
- For lab-processed kits, check the laboratory’s own certification information as a separate item.
FDA status is product-specific and can change. This guide covers how to find product information, not how to interpret a result. Ask your doctor about test selection or results. See what at-home hormone tests measure and how ovulation tests work. Browse at-home testing.
Sources
- FDA: Find All FDA-Approved Home and Lab Tests
- FDA: How to Know If FDA Regulates an OTC Test
- FDA: Home-Use Tests
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Common questions
Where can I check whether an at-home test is FDA approved or cleared?
Search the FDA IVD database by product, test type, company or another key term, then open the product record.
Does a CLIA-certified lab mean the test is FDA cleared?
Laboratory certification and a test product's FDA status are separate details. Check the specific test record and the laboratory information.
What should I do with a test result?
Follow the product instructions and contact your doctor to discuss results or questions about your health.