Correction: FDA Authorizes OTC COVID-19 Test

Detect Covid-19 Test is the 11th COVID-19 OTC Test to be FDA Authorized

If your email program has trouble displaying this email, view as a webpage. FDA Authorizes 11th COVID-19 Over-the-Counter Test The U.S. Food and Drug Administration (FDA) authorized the 11th over-the-counter (OTC) COVID-19 test. The FDA is committed to increase the availability of accurate and reliable at-home COVID-19 diagnostic tests and to facilitating consumer access to these tests. The FDA issued an emergency use authorization (EUA) for the Detect Covid-19 Test, an OTC COVID-19 diagnostic molecular test. The test requires the use of a compatible smartphone and a downloadable app to provide testing instructions and delivers results in about one hour. The test can be used as: A single test for people with COVID-19 symptoms. A serial test for people without symptoms. A serial test means the test is done two times over three days. The test can be used for people: Age 14 years or older with a self-collected nasal swab sample. Age 2 years and older when an adult collects the nasal swab sample. Questions? If you have questions about OTC COVID-19 tests, contact the Division of Industry and Consumer Education.

Follow us on Twitter at @FDADeviceInfo Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA