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China NMPA legacy archive 苏械注准20242402182

Thrombin-Antithrombin III Complex Test Kit (Chemiluminescence Immunoassay)

凝血酶-抗凝血酶Ⅲ复合物测定试剂盒(化学发光免疫分析法)
Suzhou Lihe Biomedical Engineering Co., Ltd.Class IINMPAApproved November 22, 2024
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.质控品1:1×冻干品(选配),质控品2:1×冻干品(选配)
50人份/盒,100人份/盒,200人份/盒。质控品1:1×冻干品(选配),质控品2:1×冻干品(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20242402182
Approval date
November 22, 2024
Expiry date
November 21, 2029
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
Room 501, Building B11, Bionanopark, No. 218 Xinghu Street, Suzhou Industrial Park
苏州工业园区星湖街218号生物纳米园B11号楼501室
Production facility
Production address
苏州市工业园区赵家上路7号
Intended use
English

用于体外定量测定人血浆中凝血酶-抗凝血酶Ⅲ复合物(TAT)的含量.

中文

用于体外定量测定人血浆中凝血酶-抗凝血酶Ⅲ复合物(TAT)的含量。

Structure and composition
English

试剂1:含生物素标记的凝血酶单克隆抗体①(约0.5mg/L,鼠源性),0.05M Tris缓冲液,pH7.4(含1%牛血清白蛋白,0.1% proclin 300);试剂2:含吖啶酯标记的抗凝血酶Ⅲ复合物单克隆抗体②(约0.5mg/L,鼠源性),0.05M Tris缓冲液,pH7.4(含1%牛血清白蛋白,0.1% proclin 300);试剂M:含链霉亲和素包被的磁颗粒(约0.3mg/mL),含0.1% proclin 300;系列校准品:含凝血酶-抗凝血酶Ⅲ复合物抗原(人源性),0.01M磷酸盐蛋白缓冲液(0.1% Proclin300);浓度分别约为0 ng/mL、1.0ng/mL、4.0 ng/mL、10.0ng/mL、40.0 ng/mL、120.0ng/mL,冻干品;质控品1:含凝血酶-抗凝血酶Ⅲ复合物抗原(人源性)约4.0 ng/mL,0.01M磷酸盐蛋白缓冲液(含0.1% proclin 300),冻干品;质控品2:含凝血酶-抗凝血酶Ⅲ复合物抗原(人源性)约10.0 ng/mL,0.01M磷酸盐蛋白缓冲液(含0.1% proclin 300),冻干品.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(两点定标时启用);

中文

试剂1:含生物素标记的凝血酶单克隆抗体①(约0.5mg/L,鼠源性),0.05M Tris缓冲液,pH7.4(含1%牛血清白蛋白,0.1% proclin 300);试剂2:含吖啶酯标记的抗凝血酶Ⅲ复合物单克隆抗体②(约0.5mg/L,鼠源性),0.05M Tris缓冲液,pH7.4(含1%牛血清白蛋白,0.1% proclin 300);试剂M:含链霉亲和素包被的磁颗粒(约0.3mg/mL),含0.1% proclin 300;系列校准品:含凝血酶-抗凝血酶Ⅲ复合物抗原(人源性),0.01M磷酸盐蛋白缓冲液(0.1% Proclin300);浓度分别约为0 ng/mL、1.0ng/mL、4.0 ng/mL、10.0ng/mL、40.0 ng/mL、120.0ng/mL,冻干品;质控品1:含凝血酶-抗凝血酶Ⅲ复合物抗原(人源性)约4.0 ng/mL,0.01M磷酸盐蛋白缓冲液(含0.1% proclin 300),冻干品;质控品2:含凝血酶-抗凝血酶Ⅲ复合物抗原(人源性)约10.0 ng/mL,0.01M磷酸盐蛋白缓冲液(含0.1% proclin 300),冻干品。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(两点定标时启用);

Storage conditions and expiration
English

未开封的试剂、校准品及质控品2-8℃环境下储存,有效期18个月;开封的试剂,2-8℃环境下可稳定保存60天;复溶后的校准品,2-8℃环境下可稳定保存8小时,≤-15℃环境下储存60天;复溶后的质控品,2-8℃环境下可稳定保存72小时,≤-15℃环境下储存60天.

中文

未开封的试剂、校准品及质控品2-8℃环境下储存,有效期18个月;开封的试剂,2-8℃环境下可稳定保存60天;复溶后的校准品,2-8℃环境下可稳定保存8小时,≤-15℃环境下储存60天;复溶后的质控品,2-8℃环境下可稳定保存72小时,≤-15℃环境下储存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 Thrombin-Antithrombin III Complex Test Kit (Chemiluminescence Immunoassay), registration 苏械注准20242402182. 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.