Aptima BV Assay; Aptima CV/TV Assay
K号: K243345 · 2024-11-25
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决定日期2024-11-25
产品代码PQA
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器械摘要
Aptima BV Assay; Aptima CV/TV Assay is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2024-11-25 under 510(k) number K243345. 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 Aptima BV Assay; Aptima CV/TV Assay?
Aptima BV Assay; Aptima CV/TV Assay is a medical device that received FDA 510(k) clearance on 2024-11-25. The listed applicant is Hologic, Inc.. The 510(k) number is K243345.
When did Aptima BV Assay; Aptima CV/TV Assay receive FDA 510(k) clearance?
Aptima BV Assay; Aptima CV/TV Assay received FDA 510(k) clearance on 2024-11-25, under 510(k) number K243345.
Who is the listed applicant for Aptima BV Assay; Aptima CV/TV Assay?
FDA 510(k)记录中列出了Hologic, Inc.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 Aptima BV Assay; Aptima CV/TV Assay?
The FDA product code for Aptima BV Assay; Aptima CV/TV Assay 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Hologic, Inc.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 CompanyK231381Xpert Xpress MVP；GeneXpert Xpress 系统CepheidK223653BD 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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