China-based molecular diagnostics specialist, Sansure Biotech Inc., (SHA: 688289), has announced that it has received CE IVDR certifications in the European Union for two of its fully automatic chemiluminescence immunoassay analyzer products. This regulatory milestone marks a significant step forward for the company in expanding its presence in the EU market.
Products Certified and Their Impact
The products that have been certified are the Surelite 8 and Surelite 16, fully automatic chemiluminescence immunoassay analyzers. These analyzers will join the company’s existing immune diagnostic product portfolio, which already includes 60 chemiluminescence-based detection kits. The kits cover a wide range of diagnostic areas such as procalcitonin detection (PCT) and high sensitivity troponin (hs-cTnI), encompassing inflammation, myocardial markers, tumor markers, thyroid function, sex hormones, glucose metabolism, and growth and development.
Enhancing Diagnostic Capabilities
The addition of the Surelite 8 and Surelite 16 to Sansure Biotech’s product line strengthens the company’s position as a comprehensive solution provider in the molecular diagnostics space. The new analyzers are expected to enhance the company’s capabilities in offering accurate and efficient diagnostic solutions to the European market, contributing to improved patient care and clinical decision-making.- Flcube.com
