FDA 510(k)

Xpert Xpress CoV-2/流感/RSV plus

K号: K242071 · 2025-01-10

决定日期2025-01-10

产品代码QOF

咨询委员会抱歉，您提供的内容“MI”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Xpert Xpress CoV-2/Flu/RSV plus is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid. It received FDA 510(k) clearance on 2025-01-10 under 510(k) number K242071. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Xpert Xpress CoV-2/Flu/RSV plus?

Xpert Xpress CoV-2/Flu/RSV plus is a medical device that received FDA 510(k) clearance on 2025-01-10. The listed applicant is Cepheid. The 510(k) number is K242071.

When did Xpert Xpress CoV-2/Flu/RSV plus receive FDA 510(k) clearance?

Xpert Xpress CoV-2/Flu/RSV plus received FDA 510(k) clearance on 2025-01-10, under 510(k) number K242071.

Who is the listed applicant for Xpert Xpress CoV-2/Flu/RSV plus?

FDA 510(k)记录中列出Cepheid为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Xpert Xpress CoV-2/Flu/RSV plus?

The FDA product code for Xpert Xpress CoV-2/Flu/RSV plus is QOF.

列明Cepheid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。

K261336Xpert呼吸检测板 K261362Xpert 出血热检测设备 K261867Xpert Carba-R K253653Xpert 出血热检测设备 K251721Xpert GI 面板 K250996Xpert Xpress CoV-2/流感/RSV plus

查看所有 38 个设备 →

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。