Dongfang Bio-Technology has recently announced a significant accomplishment: the company and its wholly-owned subsidiaries, Hengjian USA and Shanghai Wanzijian Biotechnology, have successfully secured multiple medical device registration certificates. Among these, the domestic certificates encompass the Influenza A and B Virus Antigen Test Kit (Colloidal Gold Method, Professional Edition), alongside the Anti-Myeloperoxidase Antibody, Anti-Proteinase 3 Antibody, and Anti-Glomerular Basement Membrane Antibody Test Kits (Flow Fluorescence Luminescence Method). Overseas, the company has obtained registrations for the Healgen® Immunofluorescence Analyzer (OG-H180) and the Healgen® AccuFluor Fentanyl Fluorescence Immunoassay Kit (FIA, Qualitative).
These newly acquired registration certificates are poised to significantly bolster Dongfang Bio-Technology's product portfolio, anticipated to strengthen its market position and competitiveness. Nonetheless, the company has cautioned that the actual sales performance of these novel products remains unpredictable at this juncture.
