Shandong Oriental Ocean subsidiary gets medical device registration for PCT kit

Shandong Oriental Ocean Sci-Tech Co., Ltd. announced today that its wholly-owned subsidiary, AIVIC Biotechnology Co., Ltd., has obtained a medical device registration certificate for its Procalcitonin (PCT) Detection Kit (Fluorescence Immunochromatography Assay). The certificate, issued by the Shandong Provincial Medical Products Administration, is valid from December 11, 2025, to December 10, 2030, with registration number Lu Xie Zhu Zhun 20252400747. This product is designed for the in vitro quantitative detection of procalcitonin in human serum, plasma, and whole blood samples.

The company cautioned investors that the product's launch and its impact on performance are subject to uncertainty, as AIVIC Biotechnology's contribution to the company's overall performance is currently minimal. The product has not yet commenced production, and actual sales will be influenced by market expansion efforts and demand. Shandong Oriental Ocean Sci-Tech will provide further updates as the situation evolves, adhering strictly to information disclosure requirements.