FDA test records identify an exact product, manufacturer, test type, and regulatory submission. Search the product name and compare the record with the box and instructions for the test you are reviewing.
FDA records are product-specific. A general statement about home pregnancy tests does not establish the status of every test kit sold under a similar description.
Check the record
- Copy the test name, manufacturer, and model or catalog identifier from the box and product page.
- Search the FDA’s over-the-counter test database.
- Compare the exact product and manufacturer in the result with the item you are reviewing.
- Check the test type, regulatory pathway, submission number, decision, and listed device classification.
- Read the manufacturer’s labeling and the FDA record together.
- Keep any claims about timing, result interpretation, or medical decisions outside a device-status summary.
For an example, the FDA’s record for the Easy@Home Pregnancy Rapid Test Midstream identifies a specific product and manufacturer. The FDA’s home-test glossary distinguishes cleared, approved, exempt, and over-the-counter test terms.
For another fertility product record, read Natural Cycles FDA De Novo status. For a powered medical device category, see powered breast pump classification. Browse at-home tests.
This page describes test labeling and regulatory records. Speak with a doctor about reproductive health concerns or medical decisions.
Sources
- Over-the-counter test database, FDA
- Easy@Home Pregnancy Rapid Test Midstream record, FDA
- Home-use tests glossary, FDA
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Common questions
Does an FDA home-test record identify a specific brand?
Yes. The product-level record includes a test name and manufacturer.
Do the words FDA cleared and FDA approved mean the same thing?
No. FDA's glossary describes cleared and approved tests as different regulatory pathways.
Can one pregnancy test record cover another brand?
No. Compare the exact test name and manufacturer listed in the record.