Thrombin-Antithrombin III Complex Test Kit (Chemiluminescence Immunoassay)
- 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 number
- 苏械注准20242402182
- Approval date
- November 22, 2024
- Expiry date
- November 21, 2029
- 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 address
- 苏州市工业园区赵家上路7号
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.
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。
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);
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）；
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.
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。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Thrombin-Antithrombin III Complex Test Kit (Chemiluminescence Immunoassay) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 苏械注准20242402182 and owned by Suzhou Lihe Biomedical Engineering Co., Ltd.. The device was approved on November 22, 2024.
This page provides complete registration details including registrant information, province location (Jiangsu), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.