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陕西省医疗器械质量监督检验院 >> 信息动态 >> 最新动态 >> 正文
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陕西省医疗器械质量监督检验院 >>最新动态 >> 正文
陕西省医疗器械质量监督检验院 生物安全实验室等级申报顺利获批
作者:未知 信息来源:本站原创 点击数:214 更新时间:2020/5/20 2:26:56

近日,省器械检验院顺利通过陕西省西咸新区教育卫体局资质审查,取得了P2级生物安全实验室行政许可。

年初新冠疫情肆虐,省器械院党委从器械质量监管及疫情防控需求出发,提出申报P2实验室及其许可资质,加强对病原微生物的检测能力和与之相关科研项目投入力度,开展包括组织工程产品病毒灭活验证、新冠肺炎试剂盒检测、致病菌分离鉴定、基因扩增检验等具有风险防护要求的生物学项目,解决我省企业的产品注册时间长、成本高的问题。经多方准备,审批组通过对我院管理体系、场地设施、防护条件、人员能力等方面进行综合评定,我院主楼124间生物安全实验室获批。

本次获批,标志着器械检验院在生物学检验领域能力再次扩展提升,为今后助力疫情防控,应对生物安全风险,开展科学监管和创新检验研究奠定了坚实基础。

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