OWF
- 产品代码
- OWF
- 器械名称
- Immunohistochemical Assay, Helicobacter Pylori
- 管理类别
- 第 1 类（Class I）
- 21 CFR 条款
- 21 CFR 866.3110
- FDA 专业组
- Microbiology
- 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)
- 1 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
Anti-helicobacter pylori rabbit monoclonal primary antibody is designed to qualitatively detect the presence of helicobacter pylori in formalin-fixed, paraffin-embedded gastric biopsy tissue via light microscopy. Immunohistochemical staining with this antibody product may aid in the diagnosis of helicobacter pylori infection. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls. This antibody is intended for in vitro diagnostic (IVD) use
FDA 官方分类页： OWF
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。