FDA 510(k)

Xpert 耐甲氧西林金黄色葡萄球菌/金黄色葡萄球菌皮肤软组织感染检测

K号: K243625 · 2024-12-18

决定日期2024-12-18

产品代码NQX

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 MRSA/SA SSTI is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid®. It received FDA 510(k) clearance on 2024-12-18 under 510(k) number K243625. The device is classified under product code NQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Xpert MRSA/SA SSTI?

Xpert MRSA/SA SSTI is a medical device that received FDA 510(k) clearance on 2024-12-18. The listed applicant is Cepheid®. The 510(k) number is K243625.

When did Xpert MRSA/SA SSTI receive FDA 510(k) clearance?

Xpert MRSA/SA SSTI received FDA 510(k) clearance on 2024-12-18, under 510(k) number K243625.

Who is the listed applicant for Xpert MRSA/SA SSTI?

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 MRSA/SA SSTI?

The FDA product code for Xpert MRSA/SA SSTI is NQX.

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 K250995Xpert 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。