Sep 16, 2025 · The table below is updated regularly and lists FDA-authorized at-home OTC COVID-19 diagnostic tests, who can use the test, links to home use instructions for each test, …

Following initial FDA authorization, FDA has extended and authorized shelf-life expiration dates after reviewing real-time data generated by the IVD manufacturer.

The FDA does not recommend using at-home COVID-19 diagnostic tests beyond their authorized expiration dates, which, as noted above, may go beyond the date printed on the box.

Complete and submit the report online through the FDA’s MedWatch website. Download the form or call 1-800-332-1088 to request a form, then complete and return to the address on the form …

Feb 24, 2025 · The page lists the COVID-19 tests that were FDA reviewed for safety and effectiveness and authorized for marketing under traditional premarket authorities.

Facts and news you can trust from the FDA about COVID-19 tests, treatments, and vaccines.

Nov 8, 2023 · Existing emergency use authorizations (EUAs) for devices relating to COVID-19 remain in effect under section 564 of the Federal Food, Drug, and Cosmetic Act.

Since the Secretary’s declaration under section 564 of the Federal Food, Drug, and Cosmetic Act related to in vitro diagnostic tests for COVID-19, on February 4, 2020, the FDA has granted …

ACON Laboratories, Inc: Flowflex COVID-19 Antigen Home Test 21-month to 24-month self-life extension granted by the FDA on March 15, 2023

Sep 3, 2025 · On November 1, 2022, the FDA revised the authorized uses and required updates to product labeling regarding repeat, or serial, testing, for all currently authorized SARS-CoV-2 …