![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Qiagen Ships Coronavirus Test Kits to U.S.
Qiagen Ships Coronavirus Test Kits to U.S.
![QIAGEN logo](https://www.fdanews.com/ext/resources/test/Device_Images/Qiagen_Logo.gif?t=1585256678&width=430)
March 25, 2020
German devicemaker Qiagen announced that it is sending its QIAstat-Dx coronavirus diagnostic tests to the U.S. after the FDA adopted a new policy to accelerate COVID-19 test availability.
The company will seek an emergency use authorization from the agency, which is usually required before a product can be released.
The nucleic acid test can tell the difference between SARS-CoV-2, the coronavirus that causes COVID-19, and 20 other respiratory infections in patients who may be showing similar symptoms.
The test kit requires less than one minute for sample preparation and produces results in about an hour.
Upcoming Events
-
21Oct