Xpert Respiratory Panel
K 號：K261336 · 2026-09-25
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器材摘要
Xpert Respiratory Panel is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K261336. 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 Xpert Respiratory Panel?
Xpert Respiratory Panel is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Cepheid. The 510(k) number is K261336.
When did Xpert Respiratory Panel receive FDA 510(k) clearance?
Xpert Respiratory Panel received FDA 510(k) clearance on 2026-09-25, under 510(k) number K261336.
Who is the listed applicant for Xpert Respiratory Panel?
The FDA 510(k) record lists Cepheid as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Xpert Respiratory Panel?
The FDA product code for Xpert Respiratory Panel is QOF.
相關臨床試驗
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其他以 Cepheid 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。
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。
K263054BIOFIRE Respiratory Panel 2.1 (RP2.1)Biofire DiagnosticsK261837FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.K252932Fast PCR Mini Respiratory PanelAutonomous Medical Devices IncorporatedK252269FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.K251742VELO Respiratory TestLex Diagnostics LimitedK251978LIAISON NES FLU A/B, RSV & COVID-19Diasorin Molecular, LLC
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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