| 审查小组 | PA |
| 医学专业 | HE |
| 产品代码 | NPQ |
| 设备名称 | Test, Factor V Leiden Mutations, Genomic Dna Pcr |
| 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 | 864.728 |
| 提交类型ID | 510(K) |
| 定义 | In vitro diagnostic test to detect the Factor V Leiden mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. |
| 物理状态 | |
| 技术方法 | |
| 目标区域 | |
| 植入式 | N |
| 维护生命设备 | N |