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Total Protein
国食药监械(进)字2008第2401040号(变更批件2)
250 South Kraemer Blvd,Brea CA 92821,USA
2008-04-26
2012-04-25
美国
变更内容:1生产企业名称由“Beckman CoulterBiomedical Limited”变更为“Beckman Coulter,Inc.”;2生产企业注册地址由“Arthur Cox Building,Earlsfort Terrace,DUBLIN 2, Ireland”变更为“250South Kraemer Blvd,Brea CA92821,USA”。申请人根据变更内容自行修订注册产品标准、说明书和包装标签中相应内容。审批结论:根据《体外诊断试剂注册管理办法》(试行),经审查,予以变更。本
Lismeehan O`Callaghans Mills County Clare,Ireland
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