| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| OYX | Bcr/Abl1 Monitoring Test | 第 2 类 | 21 CFR 866.6060 | 6 |
| PSU | Jak2 Gene Mutation Detection Test | 第 2 类 | 21 CFR 866.6070 | 2 |
| QAZ | Cancer Predisposition Risk Assessment System | 第 2 类 | 21 CFR 866.6090 | 4 |
| QDI | Fish Based Detection Of Chromosomal Abnormalities From Patients With H | 第 2 类 | 21 CFR 864.1880 | 1 |
| QDJ | Direct-To-Consumer Access Pharmacogenetic Assessment System | 第 2 类 | 21 CFR 862.3364 | 3 |
| QIC | Hiv-1 Genotyping Assay Using Ngs Technology | 第 2 类 | 21 CFR 866.3955 | |
| QNC | Whole Exome Sequencing Constituent Device | 第 2 类 | 21 CFR 866.6000 | 1 |