SML Genetree has obtained CE validation from the European Commission.
SEOUL, Korea, April 22, 2020 – SML Genetree has obtained CE-IVD (In Vitro Diagnostics) from the European Commission, allowing the use of SML Genetree’s Ezplex® SARS-CoV-2 G Kit in the EU markets.
Medical devices in the EU undergo a conformity assessment, demonstrating legal requirements, and ensuring safety. A CE (Conformité Européenne) mark is received upon the passing of all standards. SML Genetree’s Ezplex® SARS-CoV-2 G Kit utilizes an innovative multiplex, real-time polymerase chain reaction (PCR), detecting 2 target genetics (RdRp, N). Automated analysis systems enable throughput at scale.
SMLGenetree’s Ezplex® SARS-CoV-2 G Kit has proven to deliver 100% sensitivity and 100% specificity in tests administered by Korean and Japanese laboratories. Sensitivity is the ability of a test to correctly identify those with the disease (true positive rate), whereas test specificity is the ability of the test to correctly identify those without the disease (true negative rate).
About SML Genetree
SML Genetree is a leading developer of multiplex molecular technologies and multiplex clinical molecular diagnostics. SML Genetree’s tests ensure the detection of multiple targets with sensitivity, specificity, and reproducibility while delivering the utmost level of quality, throughput, and economics. SML Genetree’s committed to being a premier molecular diagnostics company and trusted partner in pharmacogenetics, diseases, genetics, and oncology. For more information, please visit us at www.smlgenetree.com
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