Xpert Xpress MVP；GeneXpert Xpress 系统
K号: K231381 · 2023-10-19
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器械摘要
Xpert Xpress MVP; GeneXpert Xpress System is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid. It received FDA 510(k) clearance on 2023-10-19 under 510(k) number K231381. The device is classified under product code PQA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Xpert Xpress MVP; GeneXpert Xpress System?
Xpert Xpress MVP; GeneXpert Xpress System is a medical device that received FDA 510(k) clearance on 2023-10-19. The listed applicant is Cepheid. The 510(k) number is K231381.
When did Xpert Xpress MVP; GeneXpert Xpress System receive FDA 510(k) clearance?
Xpert Xpress MVP; GeneXpert Xpress System received FDA 510(k) clearance on 2023-10-19, under 510(k) number K231381.
Who is the listed applicant for Xpert Xpress MVP; GeneXpert Xpress System?
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 MVP; GeneXpert Xpress System?
The FDA product code for Xpert Xpress MVP; GeneXpert Xpress System is PQA.
相关临床试验
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。
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。
相关器械（代码：PQA）
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。
K260021cobas® BV/CVRoche Molecular Systems, Inc.K243725BD 阴道面板Becton, Dickinson and CompanyK243345Aptima BV Assay; Aptima CV/TV AssayHologic, Inc.K223653BD 阴道面板Becton, Dickinson and CompanyK221160Xpert Xpress MVP，GeneXpert Dx 系统，GeneXpert Infinity 系统CepheidK212213Xpert Xpress MVP，GeneXpert Dx 系统，GeneXpert Infinity 系统Cepheid
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。
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