FDA 510(k)

QIAstat-Dx 呼吸檢測組合 Plus；QIAstat-Dx 呼吸檢測組合 Mini

K 號：K250080 · 2025-08-27

決定日期2025-08-27

產品代碼QOF

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

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.

常見問題

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) 記錄中將 QIAGEN GmbH 列為申請人。這並不單獨確立設備製造商。

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.

其他以 QIAGEN GmbH 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262168QIAstat-Dx BCID GN Plus 抗藥性面板 K254194QIAstat-Dx BCID GPF Plus 抗藥性細菌檢測面板 K254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B K252329QIAstat-Dx Gastrointestinal Panel 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

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相關器械（代碼：QOF）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261336Xpert 呼吸檢測組合Cepheid K263054BIOFIRE 呼吸面板 2.1 (RP2.1)Biofire Diagnostics K261837FINDER 流感A&B/SARS-CoV-2檢測Baebies, Inc.K252932快速PCR迷你呼吸道面板Autonomous Medical Devices Incorporated K252269FINDER 流感A&B/SARS-CoV-2檢測Baebies, Inc.K251742VELO 呼吸測試Lex Diagnostics Limited

官方來源

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