FDA 510(k)

QIAstat-Dx 呼吸系统检测板 Plus；QIAstat-Dx 呼吸系统检测板 Mini

K号: K250080 · 2025-08-27

决定日期2025-08-27

产品代码QOF

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决定实质等同

器械摘要

QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini is the device name listed in this FDA 510(k) record. The listed applicant is QIAGEN GmbH. It received FDA 510(k) clearance on 2025-08-27 under 510(k) number K250080. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini?

QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini is a medical device that received FDA 510(k) clearance on 2025-08-27. The listed applicant is QIAGEN GmbH. The 510(k) number is K250080.

When did QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini receive FDA 510(k) clearance?

QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini received FDA 510(k) clearance on 2025-08-27, under 510(k) number K250080.

Who is the listed applicant for QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini?

FDA 510(k)记录显示QIAGEN GmbH为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini?

The FDA product code for QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini is QOF.

列明QIAGEN GmbH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。

K262168QIAstat-Dx BCID GN Plus 抗生素耐药性检测板 K254194QIAstat-Dx BCID GPF Plus 抗生素耐药性检测板 K254032QIAstat-Dx 胃肠道检测板 2；QIAstat-Dx GI Panel 2 Mini B&V；QIAstat-Dx GI Panel 2 Mini B K252329QIAstat-Dx 胃肠道检测板 2；QIAstat-Dx GI Panel 2 Mini B&V；QIAstat-Dx GI Panel 2 Mini B K250324QIAstat-Dx GI Panel 2 Mini B K243813QIAstat-Dx GI Panel 2 Mini B&V

查看所有 12 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。