FDA 510(k)

Aptima SARS-CoV-2 Assay

K号: K243396 · 2025-02-13

决定日期2025-02-13

产品代码QQX

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决定实质等同

器械摘要

Aptima SARS-CoV-2 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 2025-02-13 under 510(k) number K243396. The device is classified under product code QQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Aptima SARS-CoV-2 Assay?

Aptima SARS-CoV-2 Assay is a medical device that received FDA 510(k) clearance on 2025-02-13. The listed applicant is Hologic, Inc.. The 510(k) number is K243396.

When did Aptima SARS-CoV-2 Assay receive FDA 510(k) clearance?

Aptima SARS-CoV-2 Assay received FDA 510(k) clearance on 2025-02-13, under 510(k) number K243396.

Who is the listed applicant for Aptima SARS-CoV-2 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 SARS-CoV-2 Assay?

The FDA product code for Aptima SARS-CoV-2 Assay is QQX.

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。

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相关器械（代码：QQX）

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。

K240867cobas® SARS-CoV-2 定性检测，适用于cobas® 5800/6800/8800 系统Roche Molecular Systems, Inc.K242109Xpert® Xpress CoV-2 plus (XPRS-COV2-10)Cepheid®K241580Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)Abbott Molecular K233453应用生物系统™ TaqPath™ COVID-19诊断PCR套件Life Technologies Corporation K230440Xpert® Xpress CoV-2 plusCepheid®K231306cobas SARS-CoV-2 定性检测，适用于 cobas 5800/6800/8800 系统Roche Molecular Systems, Inc.

官方来源

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