证券代码：300406 证券简称：九强生物 公告编号：2017-037北京九强生物技术股份有限公司
关于公司医疗器械注册证书变更的公告
本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记载、误导性陈述或重大遗漏。
近日，本公司收到北京市食品药品监督管理局颁发的《医疗器械注册变更文件》，具体情况如下：
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|注册证编号：京药监械(准)字 2013 第 2401000 号||
|产品名称：胱抑素 C 测定试剂盒（胶乳免疫比浊法）||
|原内容|变更内容|
|包装规格R1:2×15mL、R2:2×15mLR1:1×40mL、R2:1×10mLR1:2×40mL、R2:1×20mLR1:1×45mL、R2:1×15mLR1:2×45mL、R2:2×45mLR1:3×45mL、R2:1×45mLR1:1×50mL、R2:1×10mLR1:3×50mL、R2:3×10mLR1:3×50mL、R2:1×30mLR1:1×60mL、R2:1×15mLR1:1×60mL、R2:1×20mLR1:2×60mL、R2: 1×30mLR1:3×60mL、R2:1×60mLR1:3×60mL、R2: 3×20mLR1:8×3.8mL、R2:4×2.6mLR1:10×4.3mL、R2:2×4.3mLR1:8×4.2mL、R2:4×2.9mLR1:6×4.3mL、R2:6×4.3mLR1:8×4.3mL、R2:2×4.3mL230测试/盒(R1:1×50 mL、R2:1×10 mL)810测试/盒(R1:3×50 mL、R2:1×30 mL )260测试/盒(R1:1×45 mL、R2:1×15 mL )780测试/盒(R1:3×45 mL、R2:1×45 mL )290测试/盒(R1:1×50 mL、R2:1×10 mL )870测试/盒(R1:3×50 mL、R2:1×30 mL )350测试/盒(R1:1×45 mL、R2: 1×15 mL )|包装规格R1:2×15mL、R2:2×15mLR1:1×8mL、R2:1×8mLR1:1×15mL、R2:1×5mLR1:1×20mL、R2:1×4mLR1:1×40mL、R2:1×10mLR1:2×40mL、R2:1×20mLR1:1×45mL、R2:1×15mLR1:2×45mL、R2:2×45mLR1:3×45mL、R2:1×45mLR1:1×50mL、R2:1×10mLR1:3×50mL、R2:3×10mLR1:3×50mL、R2:1×30mLR1:1×60mL、R2:1×15mLR1:1×60mL、R2:1×12mLR1:1×60mL、R2:1×20mLR1:2×60mL、R2: 1×30mLR1:3×60mL、R2:1×60mLR1:3×60mL、R2: 3×20mLR1:8×3.8mL、R2:4×2.6mLR1:10×4.3mL、R2:2×4.3mLR1:8×4.2mL、R2:4×2.9mLR1:6×4.3mL、R2:6×4.3mLR1:8×4.3mL、R2:2×4.3mLR1:1×55mL、R2:1×11mLR1:2×46mL、R2:2×46mLR1:1×48mL、R2:1×16mL|

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|990测试/盒(R1:3×45 mL、R2:1×45 mL )470测试/盒(R1:1×70 mL、R2:1×18 mL )1410测试/盒(R1:3×70 mL、R2:3×18 mL )校准品：5×1 mL质控品（水平1）：1×1 mL质控品（水平2）：1×1 mL质控品（水平3）：1×1 mL|230测试/盒(R1:1×50 mL、R2:1×10 mL)810测试/盒(R1:3×50 mL、R2:1×30 mL )260测试/盒(R1:1×45 mL、R2:1×15 mL )780测试/盒(R1:3×45 mL、R2:1×45 mL )290测试/盒(R1:1×50 mL、R2:1×10 mL )870测试/盒(R1:3×50 mL、R2:1×30 mL )350测试/盒(R1:1×45 mL、R2: 1×15 mL )990测试/盒(R1:3×45 mL、R2:1×45 mL )470测试/盒(R1:1×70 mL、R2:1×18 mL )1410测试/盒(R1:3×70 mL、R2:3×18 mL )180测试/盒（试剂1:2×15mL、试剂2:2×15mL）240测试/盒（试剂1:2×15mL、试剂2:2×15mL）300测试/盒（试剂1:2×15mL、试剂2:2×15mL)360测试/盒（试剂1:2×15mL、试剂2:2×15mL）180测试/盒（试剂1:1×45mL、试剂2:1×15mL）240测试/盒（试剂1:1×45mL、试剂2:1×15mL）300测试/盒（试剂1:1×45mL、试剂2:1×15mL）360测试/盒（试剂1:1×45mL、试剂2:1×15mL）180测试/盒（试剂1:1×50mL、试剂2:1×10mL）240测试/盒（试剂1:1×50mL、试剂2:1×10mL）300测试/盒（试剂1:1×50mL、试剂2:1×10mL）360测试/盒（试剂1:1×50mL、试剂2:1×10mL）470测试/盒（试剂1:1×70mL、试剂2:1×18mL）200测试/盒（试剂1:1×44mL、试剂2:1×18mL）250测试/盒（试剂1:1×44mL、试剂2:1×18.5mL）200测试/盒（试剂1:1×43mL、试剂2:1×15.5mL）250测试/盒（试剂1:1×43mL、试剂2:1×15.5mL）250测试/盒（试剂1:1×52mL、试剂2:1×15.5mL）300测试/盒（试剂1:1×52mL、试剂2:1×16mL）250测试/盒（试剂1:1×52mL、试剂2:1×13mL）300测试/盒（试剂1:1×51mL、试剂2:1×13mL）670测试/盒（试剂1:2×46mL、试剂2:2×46mL）660测试/盒（试剂1:2×46mL、试剂2:2×46mL）970测试/盒（试剂1:2×46mL、试剂2:2×46mL）670测试/盒（试剂1:2×45mL、试剂2:2×45mL）670测试/盒（试剂1:2×45mL、试剂2:2×45mL）990测试/盒（试剂1:2×45mL、试剂2:2×45mL）240测试/盒（试剂1:1×48mL、试剂2:1×16mL）340测试/盒（试剂1:1×48mL、试剂2:1×16mL）220测试/盒（试剂1:1×48mL、试剂2:1×16mL）420测试/盒（试剂1:1×48mL、试剂2:1×16mL）210测试/盒（试剂1:1×45mL、试剂2:1×15mL）310测试/盒（试剂1:1×45mL、试剂2:1×15mL）200测试/盒（试剂1:1×45mL、试剂2:1×15mL）390测试/盒（试剂1:1×45mL、试剂2:1×15mL）350测试/盒（试剂1:1×55mL、试剂2:1×11mL）320测试/盒（试剂1:1×55mL、试剂2:1×11mL）410测试/盒（试剂1:1×55mL、试剂2:1×11mL）310测试/盒（试剂1:1×50mL、试剂2:1×10mL）290测试/盒（试剂1:1×50mL、试剂2:1×10mL）360测试/盒（试剂1:1×50mL、试剂2:1×10mL）校准品(5水平)：5×1 mL, 5×2 mL|

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|适用机型本试剂盒适用九强G9800、Hitachi7020/7100/7600/7080/7180/7060/7170、LABOSPECT003/008/008AS、OlympusAU640/400/CX7、BECKMAN COULTER UniCelDXC800、BECKMAN COULTER AU480/680/5800、东芝 TBA-40FR/120FR/2000FR、罗氏cobas c 311生化分析仪、迈瑞BS-2000M、西门子DimensionEXL/RXL生化分析仪、罗氏cobas 8000全自动生化免疫分析仪（cobas c 701模块、cobas c 702模块、cobas c 502模块）、罗氏cobas 6000模块化生化免疫分析系统 （cobas c 501模块）、全自动生化分析仪G92000、岛津CL7200、西门子拜耳1800/2400。|质控品（水平1）：1×1 mL,1×2 mL质控品（水平2）：1×1 mL,1×2 mL质控品（水平3）：1×1 mL,1×2 mL适用机型本试剂盒适用九强G9800、Hitachi7020/7100/7600/7080/7180/7060/7170、LABOSPECT003/008/008AS、OlympusAU640/400/CX7、BECKMAN COULTER UniCelDXC800、BECKMAN COULTERAU480/680/5800/5811/2700、东芝TBA-40FR/120FR/2000FR/FX8、罗氏cobas c 311生化分析仪、迈瑞BS-2000M、西门子DimensionEXL/RXL生化分析仪、罗氏cobas 8000全自动生化免疫分析仪（cobas c 701模块、cobas c 702模块、cobas c 502模块）、罗氏cobas 6000模块化生化免疫分析系统 （cobas c 501模块）、全自动生化分析仪G92000、岛津CL7200、西门子拜耳1800/2400。|
|批准日期：2017 年 5 月 02 日||

上述产品医疗器械注册证书变更，丰富了公司产品的规格，更好的满足客户的需求。有利于增强公司的核心竞争力，对公司未来发展具有正面影响，对近期的生产经营和业绩不会产生重大影响，敬请投资者注意风险。
特此公告。
北京九强生物技术股份有限公司董事会