PBA

Ecarin Clotting Time

产品代码

PBA

器械名称

Ecarin Clotting Time

管理类别

第 F 类（HDE）

FDA 专业组

Unknown

上市路径

HDE - Humanitarian Device Exemption

FDA 分类定义

The TAS ECT Test Card is to be used with the TAS Analyzer and is intended to determine the anticoagulant effect of hirudin during CBP in patients who have HIT. It is suited for professional use in decentralized areas of testing near the site of patient care as well as for use in the more traditional laboratory. Monitoring with the TAS ECT is indicated for persons who have been identified with and/or confirmed as a high risk for HIT, and require high dose anticoagulant with hirudin for a scheduled or emergency CPB procedure.

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）。