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前白蛋白检测试剂盒(免疫透射比浊法)
苏械注准20182400060
南京市江宁区科学园兴民南路85号二期北栋二层
2024-03-08
2028-01-03
R1:Tris缓冲液 PH6.0:50mmol\\/L、PEG-6000 :40g\\/L、Tween-20 :1g\\/L、防腐剂(叠氮钠):1g\\/L;R2:Tris缓冲液 PH6.0:50mmol\\/L、PEG-6000 :40g\\/L、羊抗人前白蛋白血清:20-30ml\\/L、防腐剂(叠氮钠):1g\\/L;校准品:重组人血清前白蛋白:0.0632g\\/L-6.32g\\/L、\\t重组人补体C3:0.407g\\/L-40.7g\\/L、\\t重组人补体C4:0.0612g\\/L-6.12g\\/L、\\t重组人免疫球蛋白IgA:0.5268g\\/L-52.68g\\/L、\\t重组人免疫球蛋白IgG:2.6753g\\/L-267.53g\\/L、\\t重组人免疫球蛋白IgM:0.3328g\\/L-33.28g\\/L、\\t重组人转铁蛋白:0.6972g\\/L-69.72g\\/L。
用于体外人血清或血浆中前白蛋白的含量检测。
2024-03-08产品技术要求、说明书变化变更由“技术要求、说明书变更情况对比表原条款及内容”变更为“技术要求、说明书变更情况对比表修改后条款及内容”包装规格变更 由“通用型\\t40mL( R1: 1×30mL+R2:1×10mL)通用型\\t200mL( R1: 2×75mL+R2: 2×25mL)通用型\\t160mL( R1: 2×60mL+R2:2×20mL)通用型\\t120mL( R1: 2×45mL+R2:2×15mL)通用型\\t180mL( R1: 3×45mL+R2:3×15mL)通用型\\t240mL( R1: 3×60mL+R2:3×20mL)通用型\\t320mL( R1: 4×60mL+R2:4×20mL)通用型\\t160mL( R1: 4×30mL+R2:4×10mL)通用型\\t50测试通用型\\t100测试通用型\\t2×200 测试德灵包装\\t( 12×52测试)( R1: 12×16.8mL+R2:12×5.8mL)罗氏包装\\t42mL( R1:2×15mL+R2:2×6mL)特种蛋白复合校准品\\t1×0.85mL(可选购)”变更为“23mL(R1:1×17mL+R2:1×6mL);40mL( R1: 1×30mL+R2:1×10mL);46mL(R1:1×34mL+R2:1×12mL);120mL(R1:2×45mL+R2:2×15mL);160mL(R1:2×60mL+R2:2×20mL);160mL(R1:4×30mL+R2:4×10mL);160mL(R1:2×60mL+R2:1×40mL);180mL(R1:2×67mL+R2:2×23mL);180mL(R1:3×45mL+R2:3×15mL);200mL(R1:2×75mL+R2:2×25mL);240mL(R1:3×60mL+R2:3×20mL);240mL(R1:3×60mL+R2:1×60mL);320mL(R1:4×60mL+R2:4×20mL);400mL(R1:3×100mL+R2:1×100mL);50测试(R1:1×17mL+R2:1×6mL);90测试(R1:1×30mL+R2:1×10mL);100测试(R1:1×34mL+R2:1×12mL);270测试(R1:2×45mL+R2:2×15mL);360测试(R1:2×60mL+R2:2×20mL);360测试(R1:4×30mL+R2:4×10mL);360测试(R1:2×60mL+R2:1×40mL);2×200 测试(R1:2×67mL+R2:2×23mL);405测试(R1:3×45mL+R2:3×15mL);450测试(R1:2×75mL+R2:2×25mL);540测试(R1:3×60mL+R2:3×20mL);540测试(R1:3×60mL+R2:1×60mL);720测试(R1:4×60mL+R2:4×20mL);900测试(R1:3×100mL+R2:1×100mL);德灵包装 ( 12×52测试)( R1: 12×16.8mL+R2:12×5.8mL);罗氏包装 42mL( R1:2×15mL+R2:2×6mL);日立008专用包装:750测试(R1:1×70mL+R2:1×27mL);亚辉龙iBC900\\/2000专用包装:1900测试(R1:3×60mL+R2:1×65mL)、570测试(R1:1×55mL+R2:1×20mL);贝克曼AU5800专用包装:1870测试(R1:3×60mL+R2:1×65mL);罗氏cobas C311\\/C501\\/C502\\/C503 专用包装:280测试(R1:1×43mL+R2:1×15mL);罗氏cobas C701\\/C702 专用包装:720测试(R1:1×75mL+R2:1×28mL)特种蛋白复合校准品 1×0.85mL(可选购)”适用仪器变化 由“本试剂通用型适用于日立7600\\/7020\\/7060;奥林巴斯AU400;Abbott Aeroset C 8000;东芝40FR;迈瑞BS-300;Beckman DXC800;DADE Behring AR;罗氏P800;迪瑞CS-300B。”变更为“试剂适用于日立7600\\/7020\\/7060、7080、7180、008AS、008α、006、3500;奥林巴斯AU400;Abbott Aeroset C8000、C4000、C16000、Alinity c;东芝40FR;迈瑞BS-300、BS-420、BS-430、BS-450、BS-460、BS-800、BS-820、BS-800M、BS-820M、BS-880、BS-890,BS-2000、BS-2200、BS-2000M、BS-2200M,BS-410、BS-410E、BS-410S、BS-470、BS-470E,BS-480、BS-490、BS-600、BS-620、BS-600M、BS-620M,BS-810、BS-810E、BS-810S,BS-830、BS-840、BS-830S、BS-850、BS-860,BS-870、BS-870E、BS-870S,BS-2800M、BS-2600M、G92000;Beckman DXC800、AU480、AU680、AU5800、DxC 700 AU;罗氏P800、Cobas c311、Cobas c501、Cobas c502、Cobas c503、Cobas c701、Cobas c702、cobas c111、cobas pro;迪瑞CS-300B、CS-400B、CS-600B、CS-1200、CS-1300A、CS-1300B、CS-1600、CS-1600A、CS-6400、CS-400、CS-1400、CS-4000、CS-680、CS-380、CS450,CS490,CS650,CS690、CS-480、CS-T300B、CS-2000I,CS-2000,CS-T180,CS-T240、CS-T300,CS-T240PLUS;日本电子株式会社BM-6010\\/C;希森美康BX-3010、BX-4000;美康MS-480、MS-880、MS-880B、MS-300、MS-200、MS-1280、MS-2080、MS-1880、MS-1680、MS-680、MS-600、MS-520、MS-450、MS-L8080、MS-L8060、MS-L8000、MS-L7280;佳能(原东芝)TBA-120FR、TBA-1500FR、TBA-2000FR、TBA-FX8;西门子ADVIA2400、ADVIA1800、Atellica CH930、ADVIA Chemistry XPT;亚辉龙iBC900-A、iBC900-B、iBC 2000-A、iBC 2000-B、iBC 2000-C。本试剂德灵包装适用于DADE Behring AR。”
南京市江宁区科学园兴民南路85号二期北栋二层
23mL(R1:1×17mL+R2:1×6mL);40mL( R1: 1×30mL+R2:1×10mL);46mL(R1:1×34mL+R2:1×12mL);120mL(R1:2×45mL+R2:2×15mL);160mL(R1:2×60mL+R2:2×20mL);160mL(R1:4×30mL+R2:4×10mL);160mL(R1:2×60mL+R2:1×40mL);180mL(R1:2×67mL+R2:2×23mL);180mL(R1:3×45mL+R2:3×15mL);200mL(R1:2×75mL+R2:2×25mL);240mL(R1:3×60mL+R2:3×20mL);240mL(R1:3×60mL+R2:1×60mL);320mL(R1:4×60mL+R2:4×20mL);400mL(R1:3×100mL+R2:1×100mL);50测试(R1:1×17mL+R2:1×6mL);90测试(R1:1×30mL+R2:1×10mL);100测试(R1:1×34mL+R2:1×12mL);270测试(R1:2×45mL+R2:2×15mL);360测试(R1:2×60mL+R2:2×20mL);360测试(R1:4×30mL+R2:4×10mL);360测试(R1:2×60mL+R2:1×40mL);2×200 测试(R1:2×67mL+R2:2×23mL);405测试(R1:3×45mL+R2:3×15mL);450测试(R1:2×75mL+R2:2×25mL);540测试(R1:3×60mL+R2:3×20mL);540测试(R1:3×60mL+R2:1×60mL);720测试(R1:4×60mL+R2:4×20mL);900测试(R1:3×100mL+R2:1×100mL);德灵包装 ( 12×52测试)( R1: 12×16.8mL+R2:12×5.8mL);罗氏包装 42mL( R1:2×15mL+R2:2×6mL);日立008专用包装:750测试(R1:1×70mL+R2:1×27mL);亚辉龙iBC900/2000专用包装:1900测试(R1:3×60mL+R2:1×65mL)、570测试(R1:1×55mL+R2:1×20mL);贝克曼AU5800专用包装:1870测试(R1:3×60mL+R2:1×65mL);罗氏cobas C311/C501/C502/C503 专用包装:280测试(R1:1×43mL+R2:1×15mL);罗氏cobas C701/C702 专用包装:720测试(R1:1×75mL+R2:1×28mL)特种蛋白复合校准品 1×0.85mL(可选购)
检测试剂在2~8℃避光保存,有效期12个月,有效期内稳定。试剂R1、R2开启后在2-8℃避光保存可稳定30天。校准品在2~8℃密闭保存稳定12个月;开启后在2~8℃保存稳定1个月。
第二类
本文件与“苏械注准20182400060 ”医疗器械注册证共同使用