东方生物:获得医疗器械注册证及新兽药证书

美港电讯
14 Nov 2024

【东方生物:获得医疗器械注册证及新兽药证书】金十数据11月14日讯,东方生物晚间公告,公司全资子公司美国衡健生物科技有限公司的新冠抗原检测试剂获得加拿大医疗器械注册证,同时其在美国的适用场景扩展至CLIAWAIVED。控股子公司杭州莱和生物技术有限公司的四款毒品检测试剂也获得国家药品监督管理局颁发的医疗器械注册证。此外,公司参与研制的禽白血病病毒AB亚群ELISA抗体检测试剂盒、非洲猪瘟病毒PCR检测试剂盒被纳入由中华人民共和国农业农村部审查批准核发的新兽药注册目录/兽药产品目录,其中,禽白血病病毒AB亚群ELISA抗体检测试剂盒成为国内首个获批的针对A/B亚群ELISA抗体检测试剂。

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