FDA 510(k)

非天花正痘病毒实时PCR引物和探针试剂盒

K号: K221834 · 2022-06-24

申请人Centers for Disease Control and Prevention

决定日期2022-06-24

产品代码PBK

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决定实质等同

器械摘要

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set 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 2022-06-24 under 510(k) number K221834. The device is classified under product code PBK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set?

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set is a medical device that received FDA 510(k) clearance on 2022-06-24. The listed applicant is Centers for Disease Control and Prevention. The 510(k) number is K221834.

When did Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set receive FDA 510(k) clearance?

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set received FDA 510(k) clearance on 2022-06-24, under 510(k) number K221834.

Who is the listed applicant for Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set?

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 Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set?

The FDA product code for Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set is PBK.

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

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官方来源

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