测试，乙型肝炎（B 抗原，B 表面抗原，Be 抗原）
PMA编号：P100001 · 2023-01-24
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决定日期2023-01-24
PMA 编号P100001
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 Ortho-Clinical Diagnostics. It received FDA 510(k) clearance on 2023-01-24. 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 2023-01-24. The listed applicant is Ortho-Clinical 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 Ortho-Clinical 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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