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FDA Enables Emergency Use of Coronavirus Test

The Food and Drug Administration on Feb. 4 issued an emergency use authorization (EUA) to enable emergency use of the Centers for Disease Control and Prevention’s (CDC’s) coronavirus (2019-nCoV) diagnostic test.

To date, the 2019-nCoV diagnostic test has been limited to use at CDC laboratories. The EUA allows any CDC-qualified laboratory across the country to use the test. Initially, 200 test kits will be distributed to U.S. domestic laboratories and another 200 will be distributed to selected international laboratories. Each test kit can evaluate up to 800 patient samples.

Additionally, CDC reported that four planes carrying passengers from Wuhan, China, back to the U.S. will arrive at designated locations in three states: California, Texas, and Nebraska. CDC staff will meet the planes and assess the health of each passenger, and all passengers will undergo the mandatory 14-day quarantine.

Visit the America’s Essential Hospitals coronavirus resources page for more information about the outbreak.

Contact Senior Director of Policy Erin O’Malley at or 202.585.0127 with questions.

About the Author

Maryellen Guinan is a principal policy analyst at America's Essential Hospitals.

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