WHO (World Health Organization) Emergency Use Assessment and Listing for Ebola Virus Disease IVDs (In Vitro Diagnostics): Public Report; Product: OraQuick® Ebola Rapid Antigen Test Kit (2019) | NLM

Disaster Information Management Research Center | NLM

WHO (World Health Organization) Emergency Use Assessment and Listing for Ebola Virus Disease IVDs (In Vitro Diagnostics): Public Report; Product: OraQuick® Ebola Rapid Antigen Test Kit (2019)

10/01/2019 12:00 AM EDT

Source: World Health Organization (WHO). Published: 10/2019. This six-page document describes the emergency use assessment and listing for Ebola virus disease in vitro diagnostics for the OraQuick® Ebola Rapid Antigen Test Kit. It consists of a desktop review of selected manufacturing and quality management system documentation; the review of any existing documentary evidence of safety and performance; and a limited performance evaluation of relevant performance characteristics of the product. (PDF)