PDY
- 产品代码
- PDY
- 器械名称
- Organophosphate Test System
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 862.3652
- FDA 专业组
- Clinical Toxicology
- 上市路径
- 需提交 510(k) 上市前通告
- FDA 历史累计 510(k)
- 1 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
For the quantitation of specific organophosphate metabolites in human urine from individuals who have signs and symptoms consistent with cholinesterase poisoning. The data obtained by this device is intended to aid in the confirmation and investigation of organophosphate exposure.
FDA 官方分类页: PDY
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。