OrientGene

14 Products Obtain Medical Device Registration Certificates

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- USTAR -

Recently, Zhejiang OrientGene Biopharmaceutical Co., Ltd. and its wholly-owned subsidiaries, American Hengjian Biotechnology Co., Ltd., Harbin OrientGene Biopharmaceutical Co., Ltd., and Shanghai Wanzijian Biotechnology Co., Ltd., in collaboration with partners, collectively achieved certifications for 14 major products both domestically and overseas.

Among these, the "Fully Automated Flow Cytometric Fluorescent Chemiluminescence Immunoanalyzer" project was co-developed by Zhejiang OrientGene Biopharmaceutical Co., Ltd.'s subsidiary, Shanghai Wanzijian Biotechnology Co., Ltd., and its cooperative unit. Based on OrientGene 's proprietary quantum dot-encoded microbeads, it integrates flow fluorescence and chemiluminescence for the first time in the industry, creating a dual-function immunoanalyzer. This fills the gap in China for a fully domestically developed, quantum dot-encoded microbead-based, and fully automated high-throughput suspension chip immune analyzer. In October 23, the project obtained medical device registration approval from the Chongqing Medical Products Administration, with the registration number: 渝械注准20232220373. The scope of application specified in the registration indicates that the instrument is "to be used with test reagents provided by Shanghai Wanzijian Biotechnology Co., Ltd.", highlighting that the Mplex-MA1600 instrument and Shanghai Wanzijian's quantum dot liquid chip diagnostic reagents form a closed detection system.

Securing these 14 certificates marks a significant breakthrough for the company in the in vitro diagnostic medical device field, further enriching its product pipeline and continually meeting the demands of the market for testing.