Autobio Diagnostics expands product portfolio with new medical device registrations

Zhengzhou Autobio Diagnostics Co., Ltd. and its wholly-owned subsidiary, Autobio Laboratory Instruments (Zhengzhou) Co., Ltd., recently announced the receipt of several medical device registration certificates from the Henan Provincial Medical Products Administration. The newly approved products, all with a five-year validity, include various immunoassay kits utilizing magnetic particle chemiluminescence. These kits detect Interleukin-4, -5, -8, and -10, as well as specific IgE antibodies for allergens like chicken egg protein, house dust, sesame, and German cockroach.

The new registrations also cover diagnostic kits for 3-Methoxytyramine and Normetanephrine, the immunosuppressant drug cyclosporine, and several autoimmune disease markers such as anti-centromere IgG, anti-SLA/LP IgG, anti-nucleosome IgG, and anti-histone IgG. Additionally, a prenatal screening risk calculation software (Model: Pre-S3) was approved, designed to assist medical institutions in assessing risks for Trisomy 21, Trisomy 18, and Neural Tube Defects based on maternal serum markers during early and mid-pregnancy.

Autobio Diagnostics stated that these new certificates enrich the company's product menu and address market demand. This expansion is expected to enhance the overall competitiveness of the company's existing diagnostic products, though its short-term impact on operating performance is anticipated to be minimal. The company cautions that actual sales performance will depend on future market promotion efforts.