杂交和/或核酸扩增检测丙型肝炎RNA，丙型肝炎病毒
PMA编号：P150015 · 2021-06-02
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决定日期2021-06-02
PMA 编号P150015
产品代码MZP
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
Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus is the device name listed in this FDA 510(k) record. The listed applicant is Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2021-06-02. The device is classified under product code MZP. It was reviewed by the MI advisory panel.
常见问题
What is the Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus?
Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus is a medical device that received FDA 510(k) clearance on 2021-06-02. The listed applicant is Roche Molecular Systems, Inc..
When did Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus receive FDA 510(k) clearance?
The clearance date for Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus can be found in the official FDA records.
Who is the listed applicant for Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus?
FDA 510(k)记录中列出罗氏分子系统有限公司为申请人。这本身并不足以确立该设备制造商的身份。
What is the FDA product code for Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus?
The FDA product code for Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus is MZP.
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关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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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