Total thyroxine detection reagent kit (magnetic microparticle chemiluminescence immunoassay method) - NMPA Registration 京械注准20242400551
Access comprehensive regulatory information for Total thyroxine detection reagent kit (magnetic microparticle chemiluminescence immunoassay method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20242400551 and owned by Baiding Biological Engineering (Beijing) Co., Ltd.. The device was approved on October 18, 2024.
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It is used for the quantitative determination of total thyroxine content in human serum in vitro.
用于体外定量测定人血清中总甲状腺素的含量。
名称主要组分浓度试剂1磷酸盐(PBS)缓冲液包被鼠源性荧光素单克隆抗体的免疫磁性微球0.05mol/L,pH7.4＞0.01%试剂2磷酸盐(PBS)缓冲液荧光素标记的鼠源性甲状腺素单克隆抗体0.05mol/L,pH7.4＞0.1ug/mL试剂3磷酸盐(PBS)缓冲液吖啶酯标记的甲状腺素抗原0.05mol/L,pH7.4＞10ng/mL校准品(液体,3水平)三羟甲基氨基甲烷(Tris)缓冲液纯化人甲状腺素0.02mol/L,pH7.4水平1目标浓度:0ng/mL水平2目标浓度:25ng/mL水平3目标浓度:100ng/mL质控品(液体,2水平)三羟甲基氨基甲烷(Tris)缓冲液纯化人甲状腺素0.02mol/L,pH7.4水平1目标浓度范围:14ng/mL～26ng/mL水平2目标浓度范围:56ng/mL～105ng/mL校准信息卡二维码(内含校准信息)校准品、质控品靶值批特异,详见瓶标签.
名称主要组分浓度试剂1磷酸盐（PBS）缓冲液包被鼠源性荧光素单克隆抗体的免疫磁性微球0.05mol/L，pH7.4＞0.01%试剂2磷酸盐（PBS）缓冲液荧光素标记的鼠源性甲状腺素单克隆抗体0.05mol/L，pH7.4＞0.1ug/mL试剂3磷酸盐（PBS）缓冲液吖啶酯标记的甲状腺素抗原0.05mol/L，pH7.4＞10ng/mL校准品（液体，3水平）三羟甲基氨基甲烷（Tris）缓冲液纯化人甲状腺素0.02mol/L，pH7.4水平1目标浓度：0ng/mL水平2目标浓度：25ng/mL水平3目标浓度：100ng/mL质控品（液体，2水平）三羟甲基氨基甲烷（Tris）缓冲液纯化人甲状腺素0.02mol/L，pH7.4水平1目标浓度范围：14ng/mL～26ng/mL水平2目标浓度范围：56ng/mL～105ng/mL校准信息卡二维码（内含校准信息）校准品、质控品靶值批特异，详见瓶标签。
2 °C ~ 8 °C protected from light, valid for 12 months.
2℃～8℃避光保存，有效期12个月。