Autobio Diagnostics and subsidiary secure 14 new device registrations

Zhengzhou Autobio Diagnostics Co. Ltd. (Autobio Diagnostics) and its wholly-owned subsidiary, Zhengzhou Saikun Biological Engineering Co. Ltd., have obtained a total of 14 new medical device registration certificates. These were issued by the National Medical Products Administration and the Henan Medical Products Administration. The certificates cover a range of diagnostic products, including an automated gene sequencing library preparation instrument, various antigen detection kits (adenovirus, respiratory syncytial virus, influenza A/B), and nucleic acid detection kits (herpes simplex virus 1+2).

The newly acquired registrations also encompass several immunoassay kits utilizing magnetic particle chemiluminescence. These are designed for the quantitative detection of specific IgE antibodies for allergens such as common ragweed, milk, peanut, house dust mite, dog dander, and cat dander. The company also secured registrations for detection kits for interleukins 1β and 2, and metanephrine. All registration certificates are valid for five years.

These new registrations are expected to enrich Autobio Diagnostics' product offerings, address market demand, and enhance the overall competitiveness of its detection products. The company anticipates a minor short-term impact on its operating performance but notes that future sales performance will depend on market promotion efforts.