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体外诊断试剂注册科普之诊断试剂常见原材料

FABUSHIJIAN:2022-03-04  LIULAN:CI

YINYAN:SHIJIYUANLIAOZAIZHENGGETIWAIZHENDUANCHANYELIANZHONGJUYOUZHONGYAODEZHANLVEYIYI,SHITIWAIZHENDUANSHIJIZHUCE、XINGNENGHESHENGCHANDEGUANJIANZHIYI,BENWENWEIDAJIAKEPUZHENDUANSHIJICHANGJIANYUANCAILIAO。

体外诊断试剂注册.jpg

体外诊断试剂注册科普之诊断试剂常见原材料:

抗原和抗体

ZHUYAOYONGYUGELEIMIANYIZHENDUANSHIZUIZHONGYAODETIWAIZHENDUANYUANLIAOZHIYI,GUANGFANYONGYUMEILIANMIANYIFENXI、HUAXUEFAGUANGMIANYIFENXI、JIAOTIJINCEXIANGCENGXI、YINGGUANGMIANYICEXIANGCENGXIDENGJIANCEPINGTAI,MUQIANGUONEISHICHANGRONGLIANGYIJINGJIEJIN30YI。KANGYUANHEKANGTIGUOJIXIANJINQIYEBAOKUOHytest,Medix,MeridianDENG。GUONEICHUANGXINCHUANGYEZAIZHEIYILINGYUJIWEIHUOYUE,XUDUOXINXIANGMUYUGUOWAIDECHAJUYUELAIYUEXIAO,DANYEYINGGAIKANDAOMUQIANZISHENMIANYI、GAOXUEYADENGDAXINGDEHEXINYUANLIAOGUONEIRENGRANWUFAZIZHUSHENGCHAN,ERQIEBUFENDANTISHICHANGJIAZHIZAI1YIYUANYISHANGDEDAZONGKANGTI(RUHbA1c、D-Dimer、CKMMDENG),GUONEICHANPINDEZHILIANGRENGWUFADADAOLINCHUANGYINGYONGDEXUQIU,JIHUQUANBUYILAIJINKOU。

酶/辅酶/酶底物

GUANGFANYONGYUSHENGHUA、MIANYI、FENZI、POCT、NINGXUE、XUETANGDENGJIHUSUOYOUDETIWAIZHENDUANZILINGYU,SHIYINGYONGZUIGUANGFANDEHEXINSHENGWUYUANLIAO。MUQIANGUONEIDEMEI/FUMEI/MEIDIWUSHICHANGYUE20YI,ZHUYAOYOULUOSHI、DONGYANGFANGDENGJINKOUPINPAIZHUDAO。MEIZHIJIXIANGGUANDECHANPINJISHUMENJIANGAOSHICHANGJIAOWEILINGSANGUONEIGEGEXIFENLINGYUFAZHANBUPINGHENG,GUONEIQIYEZAIRT-PCRFENZIZHENDUANLINGYU、NINGXUE、XUETANGDENGDALIANGSHIYONGMEIDETIWAIZHENDUANLINGYUDESHILIRENGJIAOBORUO。BUFENJICHUXINGYUANLIAORULAGENGUOYANGHUAWUMEI、KANGHUAIXUESUANYANGHUAMEIDENGLIANGDAMIANGUANGDEJICHUXINGCHANPINYANZHONGYILAIJINKOU。


磁微球/微球/NC膜

SHICIWEILIHUAXUEFAGUANG、JIAORUMIANYIBIZHUO、MIANYIYINGGUANG、YEXIANGXINPIAN、HESUANTIQUDENGGUOCHENGDEGUANJIANCAILIAOYUFANYINGZAITI。MUQIANGUONEICIZHUSHICHANGYUE2YI,JIAORUWEIQIUYUE1YI,NCMOYUE2YI,ZHEIBUFENCHANPINGUONEIZHULIUCHANGJIAJIHUQUANBUCAIYONGJINKOU,RUMerck、GE、Thermo Fisher、JSRDECHANPIN。JINNIANLAIGUONEIYIYOUYIXIETUANDUIJINXINGLEXIANGDANGSHENRUDEHEXINJISHUCHUBEI,DANMUQIANHAIMEIYOUXINGCHENGDAGUIMODEXIAOSHOU,QISHENGCHANGONGYIWENDINGXINGYUPINPAIYINGXIANGLIHAIYOUDAIJIANYAN,ZONGTIGUOCHANHUALVRENGRANJIDI。

SHIJIYUANLIAOZAIZHENGGETIWAIZHENDUANCHANYELIANZHONGJUYOUZHONGYAODEZHANLVEYIYI。SHIJIYUANLIAOSHITIWAIZHENDUANJISHUCHUANGXINDEJICHU,YUANLIAODECHUANGXINDU、XINGNENGSHUIPINGHENDACHENGDUSHANGYINGXIANGLETIWAIZHENDUANXITONGDEXINGNENG,YEJIUSHISHUOYUANLIAODEXIANJINXINGJUEDINGLEXIAYOUZHENLIAOJISHUDECHUANGXIN。XIANGYAOKAIFAXINGNENGGENGQIANGDEZHENDUANJISHUYEJIUXUYAOGAODUANDEYUANLIAOJINXINGZHICHENG。MUQIANWOGUOHEXINYUANLIAOCHANYEDALIANGYILAIJINKOU,GUOWAICHANGJIACHUYULONGDUANDIWEIDAOZHICHENGBENJUGAOBUXIA,SHIZHONGGUOQIYEZAIGUOJISHANGDEJINGZHENGLIBEIYANZHONGCHEZHOU。ERQIEZAIMAOYIZHANDEBEIJINGXIA,DALIANGJINKOUDEHEXINYUANCAILIAOCHIXUSHUNCHANGGONGYINGNANYIDEDAOCHONGFENBAOZHANG,ZAICICIGUOJIXINGUANYIQINGDECHIXUBAOFAXIA,SHIDEGUONEIQIYEDEYUANCAILIAOGONGYINGMINGXIANSHOUDAOXIANZHI。







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北京飞速度医疗科技有限公司专注于医疗器械、诊断试剂产品政策与法规规事务服务,提供产品注册申报代理、临床合同(CRO)研究、产品研发、GMP质量辅导等方面的技术外包服务。

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