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OraQuick Ebola Rapid Antigen Test


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OraQuick Ebola Rapid Antigen Test



This document describes the FDA's approval of the marketing of a rapid diagnostic test (RDT) to detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola (cadaveric oral fluid).




The OraQuick Ebola Rapid Antigen Test is an in vitro diagnostic single-use immunoassay for the qualitative detection of antigens from viruses within the Ebolavirus genus but does not differentiate between these viruses.Testing with the OraQuick Ebola Rapid Antigen Test must only be performed when public health authorities have determined the need for this test (FDA).


Free online letter/notice.