FDA 510(k)

QIAstat-Dx 脊髓腦膜炎/腦炎（ME）面板

K 號：K242256 · 2024-10-29

決定日期2024-10-29

產品代碼PLO

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 Meningitis/Encephalitis (ME) 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 2024-10-29 under 510(k) number K242256. The device is classified under product code PLO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the QIAstat-Dx Meningitis/Encephalitis (ME) Panel?

QIAstat-Dx Meningitis/Encephalitis (ME) Panel is a medical device that received FDA 510(k) clearance on 2024-10-29. The listed applicant is QIAGEN GmbH. The 510(k) number is K242256.

When did QIAstat-Dx Meningitis/Encephalitis (ME) Panel receive FDA 510(k) clearance?

QIAstat-Dx Meningitis/Encephalitis (ME) Panel received FDA 510(k) clearance on 2024-10-29, under 510(k) number K242256.

Who is the listed applicant for QIAstat-Dx Meningitis/Encephalitis (ME) Panel?

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 Meningitis/Encephalitis (ME) Panel?

The FDA product code for QIAstat-Dx Meningitis/Encephalitis (ME) Panel is PLO.

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 K250080QIAstat-Dx 呼吸檢測組合 Plus；QIAstat-Dx 呼吸檢測組合 Mini K250324QIAstat-Dx GI Panel 2 Mini B

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相關器械（代碼：PLO）

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。

K190219Simplexa VZV Direct，Simplexa VZV 正規化試劑包Diasorin Molecular, LLC K160462FilmArray 膿腦炎（ME）面板，與 FilmArray Torch 配合使用Biofire Diagnostics, LLC

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。