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体外诊断试剂产品技术要求中质控品及校准品的性能指标是否需要考虑均一性?

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la4778 一阶会员 User from: 广东省深圳市
2024-05-01 17:51

对于单独注册的质控品或校准品、包含质控品和/或校准品且能报告具体量值的体外诊断试剂,技术要求中性能指标应至少包括质控品和/或校准品的均一性指标,其他指标可依据产品具体情况进行设置。


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