QIAstat-Dx BCID GN Plus AMR Panel
K 號：K262168 · 2026-09-24
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器材摘要
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.
常見問題
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.
誰是QIAstat-Dx BCID GN Plus AMR Panel的列名申請人？
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.
相關臨床試驗
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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。
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相關器械（代碼：PEN）
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。
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官方來源
在 FDA 資料庫中查看 →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。
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