The FilmArray® NGDS BT-E Assay is for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) on the FilmArray Instrument using whole blood, plasma and serum specimens from individuals with signs and symptoms of Ebola virus infection or who are at risk for exposure or may have been exposed to the Ebola Zaire virus (detected in the West Africa outbreak in 2014) in conjunction with epidemiological risk factors, by laboratories designated by the Department of Defense (DoD).
• This test has not been FDA cleared or approved;
• This test has been authorized by FDA under an Emergency Use Authorization for use by laboratories designated by DoD;
• This test has been authorized only for the detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) and not for any other viruses or pathogens; and
• This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Ebola Zaire virus under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Issuance of this EUA follows the August 5, 2014, issuance of the HHS Secretary’s declaration that circumstances exist to justify issuance of EUAs for Ebola diagnostics; the HHS declaration was based on the existing Department of Homeland Security (DHS) Material Threat Determination issued for Ebola virus in 2006.
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