PCG
- 产品代码
- PCG
- 器械名称
- 21-Hydroxylase Antibody (21-Ohab)
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 866.5660
- 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)
- 2 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
For semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The assay may be useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency.
FDA 官方分类页： PCG
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。