MKQ

Processor, Cervical Cytology Slide, Automated

产品代码
MKQ
器械名称
Processor, Cervical Cytology Slide, Automated
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

It is a system that is used to collect and prepare cervical cytology specimens for Pap stain-based screening for cervical cancer. The specimens are collected and rinsed into a liquid preservative fluid from which they are then automatically filtered and deposited in a thin-layer on a glass microscope slide. They are stained and screened by a cytotechnologist and cytopathologist.

定义原文来自 FDA 器械分类库,属美国联邦政府作品(公有领域)。

FDA 官方分类页: MKQ
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。