免疫组织化学检测，DNA错配修复（MMR）蛋白检测
PMA编号：P210001 · 2026-01-06
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决定日期2026-01-06
PMA 编号P210001
产品代码QNH
设备分类第3类
医疗专科H
法规编号21 CFR 8
咨询委员会PA
请注意，由于您没有提供具体的医疗设备监管文本，我无法提供准确的翻译。如果您能提供具体的文本内容，我将能够为您提供准确的翻译。
器械摘要
Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay is the device name listed in this FDA 510(k) record. The listed applicant is Ventana Medical Systems, Inc. (Roche Tissue Diagnostics). It received FDA 510(k) clearance on 2026-01-06. The device is classified under product code QNH. It was reviewed by the PA advisory panel.
常见问题
What is the Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay?
Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay is a medical device that received FDA 510(k) clearance on 2026-01-06. The listed applicant is Ventana Medical Systems, Inc. (Roche Tissue Diagnostics).
When did Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay receive FDA 510(k) clearance?
The clearance date for Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay can be found in the official FDA records.
免疫组化测试、DNA错配修复（MMR）蛋白检测的列名申请人是谁？
The FDA 510(k) record lists Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) as the applicant. This does not by itself establish the device manufacturer.
什么是免疫组化测试、DNA错配修复（MMR）蛋白检测的FDA产品代码？
FDA产品代码为免疫组化测试、DNA错配修复（MMR）蛋白检测的是QNH。
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官方来源
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