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China NMPA legacy archive 苏械注准20252400195

抗甲状腺微粒体抗体测定试剂盒(化学发光免疫分析法)

Suzhou Lihe Biomedical Engineering Co., Ltd.Class IINMPAApproved February 07, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
50人份/盒,100人份/盒,200人份/盒;系列校准品:6支,1ml/支(选配)系列质控品:2支,1ml/支(选配)
Approval department
Jiangsu Provincial Drug Administration
江苏省药品监督管理局
Registration information
Registration number
苏械注准20252400195
Approval date
February 07, 2025
Expiry date
February 06, 2030
Registrant
Name
Suzhou Lihe Biomedical Engineering Co., Ltd.
苏州立禾生物医学工程有限公司
Province/Region
Jiangsu
江苏
Address
No. 7, Zhaojiashang Road, Suzhou Industrial Park
苏州工业园区赵家上路7号
Production facility
Production address
苏州工业园区赵家上路7号
Intended use
English

用于体外定量测定人血清中抗甲状腺微粒体抗体(TMA:Thyroid microsomal antibody)含量。

Structure and composition
English

试剂1:含生物素标记的甲状腺微粒体①(约0.5mg/L,重组抗原),0.05M Tris缓冲液(PH7.4,1%牛血清蛋白,0.1% Proclin300);试剂2:含吖啶酯标记的的甲状腺微粒体②(约0.5mg/L,重组抗原),0.05M Tris缓冲液(PH7.4,1%牛血清蛋白,0.1% Proclin300);试剂M:含链霉亲和素包被的磁颗粒(约0.3mg/mL),经防腐处理; 系列校准品(选配):含抗甲状腺微粒体抗体(兔源性),蛋白缓冲液(0.1% Proclin300);浓度分别约为0 IU/mL、3.0 IU/mL、10.0 IU/mL、25 IU/mL、50 IU/mL、100 IU/mL。质控品1(选配):含抗甲状腺微粒体抗体(约10.0 IU/mL,兔源性),蛋白缓冲液(0.1% Proclin300);质控品2(选配):含抗甲状腺微粒体抗体(约25.0 IU/mL,兔源性),蛋白缓冲液(0.1% Proclin300);刺穿工具1个:用于试剂瓶盖的穿刺使用;二维码标签:含试剂信息、校准品浓度、预制校准曲线(采用校准品3、校准品5校准修标);溯源性:溯源至深圳市新产业生物医学工程股份有限公司甲状腺微粒体抗体化学发光检测系统。

Storage conditions and expiration
English

1.未开封试剂、校准品及质控品2-8℃环境下储存,有效期18个月;2.开封试剂及校准品,2-8℃环境下储存,有效期60天;3.开封的质控品,2-8℃环境下储存,有效期60天。

Additional information
Appendix
产品技术要求、说明书
About this record

This static archive preserves historical registration fields and translations for 抗甲状腺微粒体抗体测定试剂盒(化学发光免疫分析法), registration 苏械注准20252400195. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.