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细胞角蛋白19片段等测定试剂盒
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透景生命:申报医疗器械注册获受理
news flash· 2025-06-16 07:58
Core Viewpoint - The company and its wholly-owned subsidiary, Shanghai Toukang Diagnostic Technology Co., Ltd., have recently received acceptance for their medical device registration applications from the Shanghai Municipal Drug Administration, which includes seven products across various diagnostic fields [1] Group 1: Product Registration - The accepted products include carcinoembryonic antigen, cytokeratin 19 fragment, neuron-specific enolase, squamous cell carcinoma antigen, gastrin-releasing peptide precursor assay kit (flow fluorescence method), 25-hydroxyvitamin D assay kit (chemiluminescent immunoassay), anti-double-stranded DNA antibody, anti-C1q antibody, anti-M2-3E antibody, anti-nucleosome antibody, and anti-phospholipid syndrome IgA antibody assay kit (flow fluorescence method) [1] - These products cover tumor detection, metabolic detection, and autoimmune detection, which will help enrich the company's product line, meet market demand, and enhance market competitiveness [1] Group 2: Approval Process - The current stage of the approval process is the acceptance of the registration application, with subsequent steps including technical review, administrative approval, and issuance of the license [1] - The acceptance of these product registration applications will not have an impact on the company's or Toukang Diagnostic's recent performance [1]