FDA approves application for kit for rapid diagnosis of Ebola virus disease
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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Ebola virus is a generic term used to refer to several viruses belonging to the virus, which belongs to the fibrous virusEVD, which is usually transmitted through blood and fluid, is a potent infectious disease that can cause Ebola haemorrhagic feverfda(http:// announcedrecently that it has approved the first application for the of the
(http://box for the rapid diagnosis of Ebola virus diseaseThe OraSure Technologiescompany(http://of the OraQuick Ebola Virus Rapid AntigenTest(http://Kit for potential patients with already EVD symptoms, as well as the bodies of patients suspected of having died from EVD, is designed to provide a rapid diagnosis of Ebola virus infection that can show positive or negative results within 30 minutes of exposure to the sampleThe OraQuick Ebola virus rapid antigen testing kit, used to diagnose blood samples from potential patients with already EVD symptoms, as well as oral fluids from bodies suspected to have died of EVDBecause the antigen levels in EVD patients in the incubation and early infection stages are not high enough, the kit cannot be used for screening testing The kit was previously awarded by the FDA for breakthrough device (http:// and was granted emergency authorization by the FDA in 2014 The OraQuick Ebola Virus Rapid Antigen Testing Kit uses an approval process called "de novo premarket review pathway." This approval process is used to approve or testing of medical device (http:// that are not available in the market
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