PZH
- 产品代码
- PZH
- 器械名称
- Serpina1 Variant Detection System
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 866.5130
- FDA 专业组
- Immunology
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- FDA 历史累计 510(k)
- 3 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
This is a qualitative DNA detection in vitro diagnostic test to be used in conjunction with a visualization instrument and its software. This test is for the simultaneous detection and identification of allelic variants found in the Alpha-1 antitrypsin (A1AT) codifying gene SERPINA1. This assessment system provides users with genetic information regarding genotypes of SERPINA1 allelic variants and is intended to be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of individuals with A1AT deficiency.
FDA 官方分类页： PZH
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。