MKT
- 产品代码
- MKT
- 器械名称
- Hepatitis Viral B Dna Detection
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 866.3174
- FDA 专业组
- Microbiology
- 上市路径
- 需提交 510(k) 上市前通告
FDA 分类定义
Nucleic acid assay for detection of Hepatitis B Virus (HBV) DNA is an in vitro nucleic acid assay for detection and quantitation of HBV DNA in human serum or plasma. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The test results must be interpreted within the context of all relevant clinical and laboratory findings.
FDA 官方分类页： MKT
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。