QTA

Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis

产品代码: QTA
器械名称: Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis
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

This is an IVD test which utilizes a next generation sequencing (NGS) method performed on a high throughput sequencing platform. This test can identify and differentiate SARS-CoV-2 and support additional genetic analysis, when clinically indicated, from SARS-CoV-2-positive samples identified as positive using an EUA authorized diagnostic test. Testing is limited to designated laboratories.

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： QTA

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。