QBD
- 产品代码
- QBD
- 器械名称
- Microbial Nucleic Acid Storage And Stabilization Device
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 866.2950
- FDA 专业组
- Microbiology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 7 件
- 其中 Summary 已存档
- 7 份,可直接下载
- FDA 历史累计 510(k)
- 17 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
Molecular transport media is a device intended for the stabilization and transportation of nucleic acids from unprocessed human samples suspected of containing infectious material.
该代码近三年的 510(k)(7 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K242820 | 2025-05-27 | Puritan Medical Products, LLC | Puritan PurSafe Plus Collection and Transport System | |
| K240797 | 2024-10-11 | Permantis Public Health | PPH Saliva Collection Kit | |
| K222771 | 2024-06-26 | Hangzhou Bioer Technology Co., Ltd. | Sample Preservative Fluid | |
| K233324 | 2024-06-17 | Alb Luz | Molecular Transport Media - MTM | |
| K221547 | 2024-06-11 | Fertipro NV | InActiv Blue | |
| K212878 | 2024-04-08 | Zhejiang Gene Science Co., Ltd. | Sample preservation solution | |
| K231013 | 2023-09-28 | Zymo Research | DNA/RNA Shield SafeCollect Saliva Collection kit |
FDA 官方分类页: QBD
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。