FDA PMA

测试，乙型肝炎（B 抗原，B 表面抗原，Be 抗原）

PMA编号：P990043 · 2021-12-21

申请人DiaSorin, Inc.

决定日期2021-12-21

PMA 编号P990043

产品代码LOM

设备分类第2类

医疗专科M

法规编号21 CFR 8

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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 DiaSorin, Inc.. It received FDA 510(k) clearance on 2021-12-21. 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 2021-12-21. The listed applicant is DiaSorin, 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 DiaSorin, 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.

官方来源

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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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