PPM

General Purpose Reagent

产品代码

PPM

器械名称

General Purpose Reagent

管理类别

第 1 类（Class I）

21 CFR 条款

21 CFR 864.4010

FDA 专业组

Pathology

上市路径

豁免 510(k)（仍须遵守通用控制与注册列名）

标记

豁免 GMP（质量体系）

该代码近三年的 510(k)

16 件

FDA 分类定义

A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test.

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）。