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科华生物HIV产品获CE IVDR Class D 认证,助力高风险体外诊断产品出海
科华生物官方公众号显示,公司研发生产的HIV人类免疫缺陷病毒抗体检测试剂盒(胶体金法)产品获得了欧盟著名公告机构TÜV SÜD Product Service GmbH依据IVDR法规签发的CE证书。科华生物也因此成为获得 Class D 高风险等级快诊产品IVDR CE证书的首家中国企业。 据了解 ...
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