COVID-19: Testing Information

Coronavirus Testing Basics

You’ve probably heard a lot about coronavirus testing recently. If you think you have coronavirus disease 2019 (COVID-19) and need a test, contact your health care provider immediately. The FDA has been working around the clock to increase the availability of critical medical products, including tests for the coronavirus, to fight the COVID-19 pandemic. Learn more about the different types of tests and the steps involved.

FDA Emergency Use Authorization (EUA)

This page has the most recent FDA information regarding COVID-EUA authorized testing. On this page, you will find the Test Kit Manufacturers and Commercial Laboratories Table. This table includes all of the tests that have received an FDA EUA authorization. Information provided on the page for each test includes manufacturer, the letter of authorization, technology, authorized settings, authorization documents, and any other documents that are available regarding the specific tests.

Important sections of the table to make sure and review for tests you are interested in are:

Diagnostic letters - provide you product details that you will need to know before administering the tests.
Authorized settings - informs you if the test has been authorized for high complexity, high and moderate complexity or CLIA waived labs.
Authorization documents – provides links to fact sheets for healthcare providers and patients, product inserts, and EUA summaries, if available.