FDA PMA

测试，乙型肝炎（B 抗原，B 表面抗原，Be 抗原）

PMA编号：P190034 · 2025-05-22

申请人Roche Diagnostics

决定日期2025-05-22

PMA 编号P190034

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 Roche Diagnostics. It received FDA 510(k) clearance on 2025-05-22. 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 2025-05-22. The listed applicant is Roche 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)?

FDA 510(k)记录显示罗氏诊断公司为申请人。这本身并不能确立该设备的制造商。

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.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

器械摘要

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