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In the September 14, 2015, Federal Register, FDA
announced the issuance of an Emergency Use Authorization
("EUA") for an in vitro diagnostic device for the
detection of the Ebola Zaire virus in response to the recent
outbreak in West Africa. FDA issued this EUA pursuant to the
Federal Food, Drug, and Cosmetic Act ("FDCA") at the
request of the applicant. Effective July 31,
2015.
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