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Sansure Biotech Gets CE Marking for Chemiluminescence Immunoassay Systems

NEW YORK — Sansure Biotech said on Wednesday that its Surelite 8 and Surelite 16 automated chemiluminescence immunoassay systems have received CE marking under the EU's In Vitro Diagnostic Regulation (IVDR).

The systems feature integrated reagents and consumables for individual sample testing, according to China-based Sansure, and are compatible with 60 existing assay kits including ones for procalcitonin (PCT) and high-sensitivity cardiac troponin testing. Its portfolio of tests are used to test for inflammation, thyroid function, tumor markers, sex hormones, glucose metabolism, and growth and development, it said.

Earlier this year Sansure partnered with the Hunan Xiangjiang Shengxiang Biological Industry Fund to invest in Shenzhen, China-based Accucise Diagnostics. During the course of 2023, that firm received medical device registration certificates in China for six electrochemiluminescence immunoassay products including reagents and controls for PCT and interleukin 6 detection, "enhancing Sansure Biotech’s strategic positioning in immunodiagnostics."

The company also offers PCR-based instruments, according to its website.