| 审查小组 | PA |
| 医学专业 | IM |
| 产品代码 | NQI |
| 设备名称 | System, Immunomagnetic, Circulating Cancer Cell, Enumeration |
| 器械分类等级 | 2 |
| 未分类原因 | |
| GMP豁免 | N |
| 第三方审核 | N |
| 审查代码 | |
| 法规编号 | 866.602 |
| 提交类型ID | 510(K) |
| 定义 | In vitro diagnostic device to aid in the enumeration of immunomagnetically selected and fluorescently identified circulating tumor cells of epithelial origin in whole blood for prediction of cancer progression and survival. |
| 物理状态 | |
| 技术方法 | |
| 目标区域 | |
| 植入式 | N |
| 维护生命设备 | N |