QBB
- 产品代码
- QBB
- 器械名称
- Placental Alpha Microglobulin-1 Immunoassay
- 管理类别
- 第 3 类（Class III）
- FDA 专业组
- Unknown
- 上市路径
- 需 PMA 上市前批准
FDA 分类定义
A Placental Alpha Microglobulin-1 Immunoassay is a qualitative test intended to detect the presence of placental alpha microglobulin 1 (PAMG-1) in cervicovaginal secretions. The test is indicated as an aid to assess the risk of spontaneous preterm delivery in less than or equal to 7 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor.
FDA 官方分类页： QBB
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。