B. anthracis 实时PCR检测
K号: K192871 · 2019-11-07
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决定日期2019-11-07
产品代码NHT
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器械摘要
B. anthracis Real-time PCR Assay is the device name listed in this FDA 510(k) record. The listed applicant is Centers for Disease Control and Prevention. It received FDA 510(k) clearance on 2019-11-07 under 510(k) number K192871. The device is classified under product code NHT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the B. anthracis Real-time PCR Assay?
B. anthracis Real-time PCR Assay is a medical device that received FDA 510(k) clearance on 2019-11-07. The listed applicant is Centers for Disease Control and Prevention. The 510(k) number is K192871.
When did B. anthracis Real-time PCR Assay receive FDA 510(k) clearance?
B. anthracis Real-time PCR Assay received FDA 510(k) clearance on 2019-11-07, under 510(k) number K192871.
Who is the listed applicant for B. anthracis Real-time PCR Assay?
The FDA 510(k) record lists Centers for Disease Control and Prevention as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for B. anthracis Real-time PCR Assay?
The FDA product code for B. anthracis Real-time PCR Assay is NHT.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Centers for Disease Control and Prevention为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K260812弗朗西斯菌属实时PCR检测K252072弗朗西斯菌属实时PCR检测K243274CDC 人类流感病毒实时RT-PCR诊断试剂盒：流感A/B分型试剂盒（VER 2）；流感A亚型鉴定试剂盒（VER 4）；流感B基因分型试剂盒（VER 1.1和2）；以及流感A/H5亚型鉴定试剂盒（VER 4）K243931CDC 人类流感病毒实时RT-PCR诊断试剂盒：流感A/B分型试剂盒（VER 2）；流感A亚型鉴定试剂盒（VER 4）；流感B谱系基因分型试剂盒（VER 1.1和2）；以及流感A/H5亚型鉴定试剂盒（VER 4）K241110CDC 人类流感病毒实时RT-PCR诊断试剂盒，流感A亚型鉴定试剂盒（Ver4）K222558非天花正痘病毒实时PCR引物和探针试剂盒
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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