Jiangsu Cowin Biotech Secures Class III Medical Device Certification for Clostridioides Difficile Detection Kit

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2 hours ago

Jiangsu Cowin Biotech Co.,Ltd. (SH: 688426) has announced that its wholly-owned subsidiary, Jiangsu Jianwei Diagnostic Technology Co., Ltd., has received the Class III Medical Device Registration Certificate (In Vitro Diagnostic Reagent) from China's National Medical Products Administration for its self-developed Clostridioides difficile tpi, toxin A, and toxin B gene detection kit (Fluorescent PCR method).

The digestive tract pathogen detection product employs fluorescent PCR technology, targeting specific sequences of the tpi, tcdA, and tcdB genes within the Clostridioides difficile genome. Specific primers and probes are designed for multiplex PCR amplification and detection of these targets.

This kit facilitates the simultaneous detection of tpi, tcdA, and tcdB genes in stool samples, providing auxiliary clinical support for diagnosing Clostridioides difficile infections.

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