Dextramer 噬巨細胞病毒套件
K 號：K153538 · 2017-03-02
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器材摘要
Dextramer CMV Kit is the device name listed in this FDA 510(k) record. The listed applicant is Immudex Aps. It received FDA 510(k) clearance on 2017-03-02 under 510(k) number K153538. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Dextramer CMV Kit?
Dextramer CMV Kit is a medical device that received FDA 510(k) clearance on 2017-03-02. The listed applicant is Immudex Aps. The 510(k) number is K153538.
When did Dextramer CMV Kit receive FDA 510(k) clearance?
Dextramer CMV Kit received FDA 510(k) clearance on 2017-03-02, under 510(k) number K153538.
Who is the listed applicant for Dextramer CMV Kit?
The FDA 510(k) record lists Immudex Aps as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Dextramer CMV Kit?
The FDA product code for Dextramer CMV Kit is GKZ.
相關臨床試驗
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：GKZ）
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。
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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