測試，乙型肝炎（B抗原、B表面抗原、Be抗原）
PMA 核准號：P210019 · 2025-10-17
廣告
決定日期2025-10-17
PMA 編號P210019
產品代碼LOM
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
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2025-10-17. The device is classified under product code LOM. It was reviewed by the MI advisory panel.
常見問題
What is the Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)?
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Siemens Healthcare Diagnostics, Inc..
When did Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) receive FDA 510(k) clearance?
The clearance date for Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) can be found in the official FDA records.
Who is the listed applicant for Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)?
FDA 510(k) 記錄將西门子醫療診斷公司列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)?
The FDA product code for Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) is LOM.
相關臨床試驗
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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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