FDA 510(k)

弗朗西斯菌属实时PCR检测

K号: K252072 · 2025-09-30

申请人Centers for Disease Control and Prevention

决定日期2025-09-30

产品代码SGA

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决定实质等同

器械摘要

Francisella tularensis 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 2025-09-30 under 510(k) number K252072. The device is classified under product code SGA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Francisella tularensis Real-time PCR assay?

Francisella tularensis Real-time PCR assay is a medical device that received FDA 510(k) clearance on 2025-09-30. The listed applicant is Centers for Disease Control and Prevention. The 510(k) number is K252072.

When did Francisella tularensis Real-time PCR assay receive FDA 510(k) clearance?

Francisella tularensis Real-time PCR assay received FDA 510(k) clearance on 2025-09-30, under 510(k) number K252072.

Who is the listed applicant for Francisella tularensis 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 Francisella tularensis Real-time PCR assay?

The FDA product code for Francisella tularensis Real-time PCR assay is SGA.

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 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 K221834非天花正痘病毒实时PCR引物和探针试剂盒

查看所有 13 个设备 →

官方来源

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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。