新华医疗(600587.SH)获得二类医疗器械注册证

Zhitongcaijing · 01/06/2022 08:26
新华医疗(600587.SH)获得二类医疗器械注册证
智通财经APP讯,新华医疗(600587.SH)发布公告,公司于近日收到山东省药品监督管理局颁发的《中华人民共和国医疗器械注册证》。具体情况如下:
(一)产品名称:血小板聚集功能(AA途径)检测试剂盒(凝固法)(二类医疗器械注册证);(二)产品名称:血小板聚集功能(ADP途径)检测试剂盒(凝固法)(二类医疗器械注册证);(三)产品名称:血小板聚集功能(ADP及AA途径)检测试剂盒(凝固法)(二类医疗器械注册证)。
上述产品主要特点:血小板聚集功能(AA途径)检测试剂盒(凝固法)、血小板聚集功能(ADP途径)检测试剂盒(凝固法)、血小板聚集功能(ADP及AA途径)检测试剂盒(凝固法)与血栓弹力图仪配套使用,体外检测人全血的血块强度,通过血块强度计算抑制率,从而判断血小板聚集功能。主要用于辅助评价冠脉心脏病、心肌梗塞等患者服用氯吡格雷或阿司匹林等药物后血小板的聚集功能。
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