OXP
- 产品代码
- OXP
- 器械名称
- Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 866.6010
- 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)
- 1 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
X/Y DNA probe kit is intended to detect alpha satellite sequences in the centromere of chromosome (Chr) X and satellite III DNA at Yq12 of Chr Y along with routine diagnostic cytogenetic testing. It is indicated for use as an adjunct to standard cytogenetic analysis for identifying and enumerating Chr X and Y via FISH in interphase nuclei and metaphase spreads obtained from bone marrow (BM) specimens in recipients of opposite-sex BM transplantation (BMT) for hematological disorders. It is not intended to be used as a stand alone assay for test reporting; in subjects with like-sex BMT; in diagnostic testing or screening for constitutional X and Y Chr aneuploidies.
FDA 官方分类页： OXP
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。