Allplex™ SARS-CoV-2 Assay

For Professional Use Only Allplex SARS-CoV-2 Assay ( RV10248X) Multiplex real-time one-step RT-PCR system for detection of SARS-CoV-2 from nasopharyngeal aspirate, nasopharyngeal swab, bronchoalveolar lavage, oropharyngeal (throat) swab, and sputum. For use with 1. Microlab NIMBUS IVD and Microlab STARlet IVD 2. Seegene NIMBUS and Seegene STARlet For use with 1. CFX96 Real-time PCR System (CFX Manager Software-IVD ) 2. CFX96 Dx System (CFX Manager Dx Software ) 3. Applied Biosystems 7500 (SDS software ) For in vitro diagnostic use only Seegene Inc., Taewon Bldg., 91 Ogeum-ro, Songpa-gu, Seoul, Republic of Korea 05548 Medical Technology Promedt Consulting GmbH Altenhofstrasse 80, D-66386 , Germany Not available in the Allplex SARS-CoV-2 Assay 2 10/2020 TABLE OF CONTENTS NOTICES ---------------------------------------- ---------------------------------------- ------------ INTENDED USE ---------------------------------------- ---------------------------------------- --- PRINCIPLES AND PROCEDURE OVERVIEW ---------------------------------------- ------ BACKGROUND INFORMATION.

Allplex™ SARS-CoV-2 Assay 3 10/2020 V1.14 NOTICES z For in vitro diagnostic use only. z The Allplex SARS-CoV-2 Assay should be performed by qualified, trained personnel. z Reliability of the results depends on adequate specimen collection, storage, transport, and

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