测试，乙型肝炎（B 抗原，B 表面抗原，Be 抗原）
PMA编号：P040004 · 2022-03-29
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决定日期2022-03-29
PMA 编号P040004
产品代码LOM
设备分类第2类
医疗专科M
法规编号21 CFR 8
咨询委员会抱歉，您提供的内容“MI”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
器械摘要
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. It received FDA 510(k) clearance on 2022-03-29. The device is classified under product code LOM. It was reviewed by the MI advisory panel.
常见问题
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 2022-03-29. The listed applicant is Siemens Healthcare Diagnostics.
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 Siemens Healthcare Diagnostics 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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官方来源
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