Further, available testing procedures may produce false negative or false positive results due to a variety of factors. As the manufacturer, SD Biosensor, transitions to this new brand, customers may receive a product with the previously authorized COVID-19 At-Home Test labeling.COVID‑19 testing does not eliminate the risk of transmission of SARS-CoV-2 or Coronavirus Disease 2019.
The Pilot COVID-19 At-Home Test, distributed by Roche Diagnostics, is previously known as the COVID-19 At-Home Test. Video: What Is an EUA? Describes how the FDA can issue an emergency use authorization (EUA) to provide more timely access to diagnostic tests that may help during the public health emergency when there is no adequate, approved, and available alternative.Isolation and Precautions for People with COVID-19 | CDC.What to Do If You Were Exposed to COVID-19 | CDC.COVID-19 Self-Testing At-Home or Anywhere | CDC.COVID-19 Testing: What You Need to Know | CDC.
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To see complete information on smaller screens, select the blue plus (+) button beside the test name.
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The FDA will update this table as additional shelf-life extensions are authorized. The table will say "See box label" instead of having a link to updated expiration dates. If the Expiration Date column does not say the shelf-life is extended, that means the expiration date on the box label of your test is still correct.Find the original expiration date on the box label of your test and then look for the new expiration date in the "updated expiration dates" table for your test. If the Expiration Date column says that the shelf-life is "extended," there is a link to "updated expiration dates" where you can find a list of the original expiration dates and the new expiration dates.To see if the expiration date for your at-home OTC COVID-19 test has been extended, first find the row in the below table that matches the manufacturer and test name shown on the box label of your test. For more information about how the expiration date is determined and why it may be extended, see the At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions. An extended expiration date means the manufacturer provided data showing that the shelf-life is longer than was known when the test was first authorized. In some cases, the expiration date for a test may be extended. The expiration date is set at the end of the shelf-life. The shelf-life is how long the test should work as expected and is measured from the date the test was manufactured. In the table below, the "Expiration Date" column lists the shelf-life and where to find the expiration date for that test. For more information about each test, including the Letter of Authorization and authorized labeling, see In Vitro Diagnostics EUAs: Tables of IVD EUAs. The table includes links to home use instructions for each test. The table below lists FDA-authorized at-home OTC COVID-19 diagnostic tests, and includes information on expiration dates, who can use the test, and other details that may help you decide what test is right for you. To see complete information on smaller screens, select the blue plus (+) button beside the test name. List of Authorized At-Home OTC COVID-19 Diagnostic Tests Testing and other protective steps like wearing a mask and COVID-19 vaccination are important to stop the spread of COVID-19 infection.įor more information, including answers to frequently asked general questions about at-home COVID-19 diagnostic tests, visit At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions. For additional information on reading and understanding your test results, see Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results.Īuthorized at-home OTC tests are available without a prescription and are typically available online or at local stores.
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