Jiangsu Cowin Biotech Co.,Ltd. (688426.SH) has announced that its wholly-owned subsidiary, Jiangsu Jianwei Diagnostic Technology Co., Ltd., has obtained a Class III Medical Device Registration Certificate (for in vitro diagnostic reagents) from China's National Medical Products Administration for its independently developed Clostridioides difficile Glutamate Dehydrogenase (GDH) Antigen and Toxin Test Kit (Enzyme-Linked Immunochromatographic Assay).

This in vitro diagnostic product for gastrointestinal pathogens utilizes a technology combining immunochromatography with enzyme-linked amplification. It enables the rapid qualitative detection of Clostridioides difficile GDH and Toxins A/B in fecal samples.

The kit integrates broad-spectrum GDH screening with specific toxin verification, allowing for "one-step operation and simultaneous dual-target detection." This design is intended to assist clinicians in rapidly distinguishing between asymptomatic colonization and active infection by Clostridioides difficile, thereby facilitating precise differential diagnosis.