NRX
- 产品代码
- NRX
- 器械名称
- Complement 4d (C4d) And Complement Receptor 1 (Cr1)
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 866.5820
- FDA 专业组
- Immunology
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
FDA 分类定义
The device is an indirect immunofluorescence assay utilizing monoclonal antibodies and flow cytometry in the quantitative determination of complement 4d (C4d) and complement receptor 1 (CR1) on the surface of erythrocytes from EDTA anti-coagulated whole blood. The C4d and CR1 results are used in a ratio as an aid in the diagnosis of systemic lupus erythematosus.
FDA 官方分类页： NRX
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。