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过敏原特异性IgE抗体检测试剂盒(食物混合FX5/磁微粒化学发光法)
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浩欧博:全资子公司获得3项医疗器械注册证
Ge Long Hui A P P· 2025-08-04 09:42
Core Viewpoint - The company, Haobio, announced that its wholly-owned subsidiary, Hunan Haobio Pharmaceutical Co., Ltd., has received approval from the Hunan Provincial Drug Administration for three medical device registration certificates, enhancing its competitive position in the market [1] Group 1 - The approved medical devices include specific IgE antibody test kits for allergens: W22, food mixed FX5 (magnetic chemiluminescence method), and inhalant mixed SX (magnetic chemiluminescence method) [1] - The acquisition of these registration certificates will enrich the company's chemiluminescence platform testing menu, potentially improving its market competitiveness [1] - The actual sales performance will depend on future market expansion efforts, and the impact on the company's future performance remains unpredictable [1]
浩欧博(688656.SH):子公司获得医疗器械注册证
Ge Long Hui A P P· 2025-08-04 09:34
Core Viewpoint - The company, Haobio (688656.SH), has recently received approval for three medical device registration certificates from the Hunan Provincial Drug Administration, which enhances its chemiluminescence platform testing menu and strengthens its market competitiveness, positively impacting sustainable development [1]. Group 1: Medical Device Registration - The first registered product is a test kit for the quantitative detection of specific IgE antibodies related to hard grass (W22), with an expiration date of July 28, 2030, intended for assisting in the treatment of allergies [2]. - The second product is a test kit for the qualitative detection of food allergen-specific IgE antibodies (food mix FX5), also expiring on July 28, 2030, used for the diagnosis of allergies [2]. - The third product is a test kit for the qualitative detection of inhalant allergen-specific IgE antibodies (inhalant mix SX), with the same expiration date, aimed at assisting in the diagnosis of allergies [3].