Sars-Cov-2 Test Kit

INCLUDES : 1 MAGICPREP FAST RNA EXTARCTION KIT Ready-to-use kit content: -Dacron Nasopharyngeal Swab with Breaking Point -Diagnotransfer Tube (full of 3ml of viral nucleid acid extractive and preservative liquid) 1 DIAGNOVITAL SARS CoV 2 Multiplex Real Time PCR Kit Ready-to-use kit content: -PCR Master Mix -Positive Control -Nuclease free dH20 It is the first local manufacturer IVD brand to get FDA EUA certificate in Turkey. â?¢Different Real Time PCR Kit versions are available according to genes of interest; whether it is N, ORF1ab, E, Rdrp and RNAse HEC with a non infectious Artificial Positive Control option. Automatized or manual extraction solutions are available according to demand. Automatized instruments vary also in terms of capacity whether it is 96 tests/run or 32 tests/run. â?¢Manual extraction category hosts two types whether it is traditional spin column extraction or lysis solution based fast extraction method called Magic Prep (please refer to Quick Pack 1 in the following pages) The quality and the compliance these products to In Vitro Diagnostic Medical Devices Directive 98 79 / is certified and marked with CE IVD by MDC Medical Device Certification GmbH in Stuttgart/Germany together with the confirmation of Paul Ehrlich Institute of Germany. Our quality management system regarding ISO 13485, GMP and requirements, covers all product realization processes. Each batch is controlled by our QC professionals according to the international standards. All the batch or lot specific quality certificates are available. *Different versions available according to genes of interest CE-IVD, FDA EUA