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Nuclein 获得 FDA 510(k) 双重批准和 CLIA 豁免
Nuclein 的 DASH SARS-CoV-2 和流感 A/B 检测已获得 FDA 的 510 (k) 批准和临床实验室改进修正案 (CLIA) 豁免。根据该公司的新闻稿,这款三合一检测将在一次不超过 15 分钟的就诊中为患者提供 COVID-19、甲型流感和乙型流感的结果。
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