Autobio Diagnostics expands product portfolio with new device approvals

Zhengzhou Autobio Diagnostics Co., Ltd. (Autobio Diagnostics) and its subsidiary, Zhengzhou Biaoyuan Biotechnology Co., Ltd., recently obtained multiple medical device registration certificates from the National Medical Products Administration. The approvals, effective from 2025 with a 5-year validity, cover a range of diagnostic kits, including several for Epstein-Barr virus (EBV) antibodies and a multiplex PCR kit for respiratory pathogens.

The newly approved products include EBV early antigen IgG and IgA antibody detection kits, EBV capsid antigen IgA antibody detection kits, and EBV nuclear antigen IgA antibody detection kits, all utilizing magnetic particle chemiluminescence. Additionally, a PCR-fluorescence probe kit for *Streptococcus pneumoniae*, *Legionella pneumophila*, and *Moraxella catarrhalis* nucleic acid detection, and a quality control product for various tumor markers, also received approval.

These new registrations are expected to enrich Autobio Diagnostics' product lineup, meet market demands, and strengthen the company's overall competitiveness. While a positive development, actual sales performance will depend on future market promotion, and the impact on the company's future operating income cannot yet be predicted. Investors are advised to be aware of potential risks.