诺辉健康拿下这一IVDR自测证

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诺辉健康作为中国首家高发癌症居家早筛生物高科技企业，其研发的幽幽管®成为全球首个获IVDR Class C自测证书的幽门螺杆菌粪便抗原检测产品。2024年，诺辉健康将幽幽管IVDR认证全流程独家委托给先诺，目标是一次交卷、快速拿证。先诺通过双国临床（匈牙利和意大利）、高标准设计（以UBT呼气试验为对照，灵敏度、特异度终点分别锁定≥95%/≥99%）、可用性研究（100名普通用户错误率仅0.8%）及...

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