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 ---------------------------------------- ---------------------- REAGENTS ---------------------------------------- ---------------------------------------- --------- STORAGE AND HANDLING.

CFX96™ Real-time PCR System (CFX Manager™ Software-IVD v1.6) 2. CFX96™ Dx System (CFX Manager™ Dx Software v3.1) 3. Applied Biosystems™ 7500 (SDS software v2.0.5) 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

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  Time, 7500, Real, Time pcr

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