OVA

Complete Gene Expression Profiling Accessory Reagents

产品代码

OVA

器械名称

Complete Gene Expression Profiling Accessory Reagents

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 862.2570

FDA 专业组

Clinical Chemistry

上市路径

豁免 510(k)（仍须遵守通用控制与注册列名）

该代码近三年的 510(k)

1 件

FDA 分类定义

Complete gene expression profiling accessory reagent kits include all components necessary to perform transcript synthesis, fluorescent labeling, and detection and are intended to carry out all processing steps for separately cleared gene expression microarray assays which specify their use. They are designed and optimized for preparation of labeled complementary RNA (cRNA) target using total RNA isolated from specific clinical tissue specimens for hybridization to and measurement of fluorescently-labeled cRNA targets using a specified and cleared microarray instrumentation system. They may also include specified exogenous controls intended to monitor amplification and labeling processes.

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）。