大盆地產生毒素C. difficile直接測試（CDF2）
K 號：K232092 · 2023-11-14
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器材摘要
Great Basin Toxigenic C. difficile Direct Test (CDF2) is the device name listed in this FDA 510(k) record. The listed applicant is Vela Operations USA. It received FDA 510(k) clearance on 2023-11-14 under 510(k) number K232092. The device is classified under product code OZN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Great Basin Toxigenic C. difficile Direct Test (CDF2)?
Great Basin Toxigenic C. difficile Direct Test (CDF2) is a medical device that received FDA 510(k) clearance on 2023-11-14. The listed applicant is Vela Operations USA. The 510(k) number is K232092.
When did Great Basin Toxigenic C. difficile Direct Test (CDF2) receive FDA 510(k) clearance?
Great Basin Toxigenic C. difficile Direct Test (CDF2) received FDA 510(k) clearance on 2023-11-14, under 510(k) number K232092.
Who is the listed applicant for Great Basin Toxigenic C. difficile Direct Test (CDF2)?
The FDA 510(k) record lists Vela Operations USA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Great Basin Toxigenic C. difficile Direct Test (CDF2)?
The FDA product code for Great Basin Toxigenic C. difficile Direct Test (CDF2) is OZN.
相關臨床試驗
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相關器械（代碼：OZN）
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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