Sansure Biotech Inc. (SHA: 688289), a leading molecular diagnostics company based in China, has announced that it has received CE IVDR certification from the European Union for its mycobacterium tuberculosis nucleic acid detection kit, which utilizes the PCR fluorescence probe method. This certification marks a significant milestone, as it grants the product the eligibility for marketing and use across EU member states and other countries that recognize the CE mark.
The mycobacterium tuberculosis nucleic acid detection kit is designed for the qualitative detection of Mycobacterium tuberculosis (MTB) DNA in human sputum samples. It serves as a critical tool for healthcare professionals in identifying individuals who are either suspected or confirmed to be infected with Mycobacterium tuberculosis, thereby aiding in the diagnosis of tuberculosis.- Flcube.com