乙型肝炎病毒DNA檢測
PMA 核准號：P150014 · 2025-10-17
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決定日期2025-10-17
PMA 編號P150014
產品代碼MKT
器械分類2 類
醫療專科M
法規編號21 CFR 8
諮詢委員會MI
(請提供完整的描述文本，以便進行翻譯。)
器材摘要
Hepatitis Viral B DNA Detection is the device name listed in this FDA 510(k) record. The listed applicant is Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2025-10-17. The device is classified under product code MKT. It was reviewed by the MI advisory panel.
常見問題
What is the Hepatitis Viral B DNA Detection?
Hepatitis Viral B DNA Detection is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Roche Molecular Systems, Inc..
When did Hepatitis Viral B DNA Detection receive FDA 510(k) clearance?
The clearance date for Hepatitis Viral B DNA Detection can be found in the official FDA records.
Who is the listed applicant for Hepatitis Viral B DNA Detection?
FDA 510(k) 記錄將羅氏分子系統公司（Roche Molecular Systems, Inc.）列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for Hepatitis Viral B DNA Detection?
The FDA product code for Hepatitis Viral B DNA Detection is MKT.
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。
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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