7 More Registrations，Special Coagulation Reagents and Coagulation Analyzer Approved on the Same Day！

On April 11, 2026, Shanghai Sun Biotech once again received seven Medical Device Registration Certificates issued by the Shanghai Municipal Drug Administration. The newly approved products include a Lupus Anticoagulant (LA) Detection Kit (dRVVT) with matched quality controls, an Anti-Xa Assay Kit with matched quality controls and calibrators, and the UG1200 Fully Automated Coagulation Analyzer.

The LA Detection Kit (dRVVT) is developed in strict accordance with China's Consensus on the Standardization of Lupus Anticoagulant Detection and Reporting. It delivers a complete, standardized report encompassing the screening ratio, confirmatory ratio, and normalized ratio, providing clinicians with a reliable basis for diagnosis and treatment decisions.

The Anti-Xa Assay Kit (chromogenic substrate method) is designed primarily for monitoring anticoagulation therapy with unfractionated heparin and low-molecular-weight heparin (LMWH). Multicenter clinical data demonstrate excellent analytical performance, with robust resistance to a wide range of potential interfering substances.

The UG1200 Fully Automated Coagulation Analyzer is purpose-built for small and medium-sized laboratories. Inheriting the UG series' proprietary integrated optical-mechanical detection technology, it supports platelet aggregation function assessment, automated APTT mixing studies, automated parallel coagulation factor testing, and low-volume sample analysis — capabilities that can meaningfully advance the coagulation testing capacity of county-level hospitals and primary care institutions.

With the approval of these new products, Shanghai Sun Biotech has further strengthened its coagulation diagnostics portfolio, continuing to drive the localization and domestic substitution of coagulation testing solutions. These innovations will help reduce healthcare costs and contribute professional expertise to enhancing coagulation diagnosis and management capabilities across all levels of medical institutions.