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FDA, At-Home OTC COVID-19 Diagnostic Tests

Feb 22 2022

FDA provides information about at-home over-the-counter (OTC) COVID-19 diagnostic tests.

These at-home COVID-19 diagnostic tests are FDA authorized for self-testing at home (or in other locations). This means you collect your own sample, perform the test, and read the result yourself without the need to send a sample to a laboratory. Authorized at-home OTC tests are available without a prescription and are typically available online or at local retailers.

Testing and other protective steps like mask-wearing and COVID-19 vaccination are essential to stop the spread of COVID-19 infection.

List of Authorized At-Home OTC COVID-19 Diagnostic Tests

This table lists FDA-authorized at-home OTC COVID-19 diagnostic tests. This table includes links to home use instructions for each test. For more information about each test, including the Letter of Authorization and authorized labeling, see In Vitro Diagnostics EUAs: Tables of IVD EUAs.

Provision Consulting Group provides consulting service and solves customer problems accurately and quickly.

Our services allow manufacturers to spend more time developing their devices

rather than searching for distributors, negotiating contracts, and learning regulations.

If you have questions about FDA regulation of medical devices

or importing of medical devices to the United States,

Office 1-909-493-3276



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