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FDA 510(k)

QIAstat-Dx BCID GN Plus AMR Panel

K号: K262168 · 2026-09-24

申请人QIAGEN GmbH
决定日期2026-09-24
产品代码PEN
咨询委员会MI
决定Substantially Equivalent

器械摘要

QIAstat-Dx BCID GN Plus AMR Panel is the device name listed in this FDA 510(k) record. The listed applicant is QIAGEN GmbH. It received FDA 510(k) clearance on 2026-09-24 under 510(k) number K262168. The device is classified under product code PEN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the QIAstat-Dx BCID GN Plus AMR Panel?

QIAstat-Dx BCID GN Plus AMR Panel is a medical device that received FDA 510(k) clearance on 2026-09-24. The listed applicant is QIAGEN GmbH. The 510(k) number is K262168.

When did QIAstat-Dx BCID GN Plus AMR Panel receive FDA 510(k) clearance?

QIAstat-Dx BCID GN Plus AMR Panel received FDA 510(k) clearance on 2026-09-24, under 510(k) number K262168.

QIAstat-Dx BCID GN Plus AMR Panel的申请人是谁？

The FDA 510(k) record lists QIAGEN GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QIAstat-Dx BCID GN Plus AMR Panel?

The FDA product code for QIAstat-Dx BCID GN Plus AMR Panel is PEN.

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。

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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。

K254194QIAstat-Dx BCID GPF Plus AMR PanelK254032QIAstat-Dx 胃肠道检测板 2；QIAstat-Dx GI Panel 2 Mini B&V；QIAstat-Dx GI Panel 2 Mini BK252329QIAstat-Dx 胃肠道检测板 2；QIAstat-Dx GI Panel 2 Mini B&V；QIAstat-Dx GI Panel 2 Mini BK250080QIAstat-Dx 呼吸系统检测板 Plus；QIAstat-Dx 呼吸系统检测板 MiniK250324QIAstat-Dx GI Panel 2 Mini BK243813QIAstat-Dx GI Panel 2 Mini B&V

查看所有 12 个设备 →

相关器械（代码：PEN）

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。

K243013LIAISON PLEX 革兰氏阴性血培养检测Luminex CorporationK243759BIOFIRE血培养鉴定2（BCID2）面板（RFIT-ASY-0147（30包装）RFIT-ASY-0148（6包装））Biofire Diagnostics, LLCK213236ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenmark Diagnostics, IncorporatedK193519BioFire 血培养鉴定 2 (BCID2) 面板Biofire Diagnostics, LLCK190341iC-GN iC-Cassette for use on the iC-SystemIcubate, Inc.K182619ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenmark Diagnostics, Incorporated

官方来源

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