说明与适用边界
此页按所列地区、版本归档。标签内容可能更新，具体产品请核对原始来源；本站关联表示阅读线索，不表示药品与器械可兼容或可替换。
监管定义 / Regulatory definition
A qualitative in vitro molecular diagnostic system used for the detection of select variants in specified cancer-related genes. The device is intended to be used on genomic DNA isolated from human specimens collected by the user. The results of the test provide users with a genetic health risk assessment for developing certain cancers. The test may not include all variants associated with a predisposition of developing cancer and is not intended to describe a persons overall risk of developing any type of cancer nor to aid in determination of treatment or act as a substitute for recommended cancer screenings or appropriate follow-up. The device is for over-the-counter use.
监管信息 / Regulatory information
FDA product code: QAZ
Device class: 2
Regulation: 866.6090
Specialty: Medical Genetics
Implant flag: N
Life sustaining/supporting flag: N
使用说明核对
该条目描述监管产品类别，不对应某个型号。实际操作须使用该厂家、型号和软件版本的说明书，核对预期用途、适应证、禁忌、校准、耗材兼容性、清洁灭菌、维护与报警处理。类别资料不能替代厂家使用说明。
来源、版本与许可
- 资料类型
- FDA 器械监管分类（非厂家操作说明书）
- 版本
- 2026-10-08
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.