FDA 510(k)

Xpert 肠道难辨梭菌/流行病学

K号: K243730 · 2025-02-28

决定日期2025-02-28

产品代码OZN

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 C. difficile/Epi is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid®. It received FDA 510(k) clearance on 2025-02-28 under 510(k) number K243730. The device is classified under product code OZN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Xpert C. difficile/Epi?

Xpert C. difficile/Epi is a medical device that received FDA 510(k) clearance on 2025-02-28. The listed applicant is Cepheid®. The 510(k) number is K243730.

When did Xpert C. difficile/Epi receive FDA 510(k) clearance?

Xpert C. difficile/Epi received FDA 510(k) clearance on 2025-02-28, under 510(k) number K243730.

Who is the listed applicant for Xpert C. difficile/Epi?

The FDA 510(k) record lists Cepheid® as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xpert C. difficile/Epi?

The FDA product code for Xpert C. difficile/Epi is OZN.

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 →

相关器械（代码：OZN）

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。

K260045cobas® Cdiff 核酸检测，用于 cobas® Liat® 系统（07454945190）；cobas® Cdiff 阳性及阴性对照试剂盒，用于 cobas® Liat® 系统（07454970190）Roche Molecular Systems, Inc.K232092Great Basin Toxigenic C. difficile Direct Test (CDF2)Vela Operations USA K212427cobas Cdiff 核酸检测，适用于 cobas Liat 系统Roche Molecular Systems, Inc.K210385cobas Cdiff 核酸检测，适用于 cobas Liat 系统Roche Molecular Systems, Inc.K172569GenePOC CDiffGenepoc, Inc.K171770cobas Cdiff 核酸检测，适用于 cobas Liat 系统Roche Molecular Systems, Inc.

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。