SDC

Qualitative Cleaning Process Protein Indicator

产品代码
SDC
器械名称
Qualitative Cleaning Process Protein Indicator
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 880.6930
FDA 专业组
General Hospital
上市路径
需提交 510(k) 上市前通告
该代码近三年的 510(k)
1 件

FDA 分类定义

A qualitative cleaning process protein indicator is intended for use by a health care provider on a cleaned medical device as an interim step prior to high level disinfection or sterilization of the cleaned medical device. The intended use is to inform the health care user of the presence of residual soil protein in the sample extract.

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)。

该代码近三年的 510(k)(1 件)

数据窗口为最近三年。最新一件:2024-11-12。

510(k) 号批准日期申请人器械名称摘要
DEN2300852024-11-12SterisVERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein
FDA 官方分类页: SDC
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。