QLW

Covid-19 Test Home Collection Kit Devices

产品代码: QLW
器械名称: Covid-19 Test Home Collection Kit Devices
管理类别: 第 N 类（Not Classified）
FDA 专业组: Unknown
上市路径: EUA - Emergency Use Authorization

FDA 分类定义

Specimens collected using the Home Collection Kit can be transported at ambient temperature for testing at a laboratory. SARS-CoV-2 RNA from the clinical specimen is maintained in the specimen packaging and suitable for use in diagnostic testing preformed using a molecular in vitro diagnostic (IVD) test for the detection of SARS-CoV-2 RNA that is authorized for use with the COVID-19 Test Home Collection Kit.

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： QLW

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。