Public report for StrongStep® Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (detection for three genes) (EUL 0519-206-00)

Overview

The EUL process is intended to expedite the availability of in vitro diagnostics needed in public health emergency situations and to assist interested UN procurement agencies and Member States in determining the acceptability of using specific products in the context of a Public Health Emergency of International Concern (PHEIC), based on an essential set of available quality, safety and performance data. The EUL procedure includes the following:

• Quality Management Systems Review and Plan for Post-Market Surveillance: desk-top review of the manufacturer’s Quality Management System documentation and specific manufacturing documents; 
• Product Dossier Review: assessment of the documentary evidence of safety and performance.