測試，乙型肝炎（B抗原、B表面抗原、Be抗原）
PMA 核准號：P000014 · 2020-10-22
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決定日期2020-10-22
PMA 編號P000014
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 Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-10-22. 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 2020-10-22. The listed applicant is Ortho-Clinical 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)?
The FDA 510(k) record lists Ortho-Clinical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.
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.
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官方來源
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