乙型肝炎病毒B DNA检测
PMA编号：P170025 · 2025-10-07
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决定日期2025-10-07
PMA 编号P170025
产品代码MKT
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
Hepatitis Viral B DNA Detection is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2025-10-07. The device is classified under product code MKT. It was reviewed by the MI advisory panel.
常见问题
What is the Hepatitis Viral B DNA Detection?
Hepatitis Viral B DNA Detection is a medical device that received FDA 510(k) clearance on 2025-10-07. The listed applicant is Hologic, Inc..
When did Hepatitis Viral B DNA Detection receive FDA 510(k) clearance?
The clearance date for Hepatitis Viral B DNA Detection can be found in the official FDA records.
Who is the listed applicant for Hepatitis Viral B DNA Detection?
FDA 510(k)记录中列出了Hologic, Inc.为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for Hepatitis Viral B DNA Detection?
The FDA product code for Hepatitis Viral B DNA Detection is MKT.
相关临床试验
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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。
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