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)
- Approval department
- Jiangsu Provincial Drug Administration
- Registration number
- 苏械注准20242402182
- Approval date
- November 22, 2024
- Expiry date
- November 21, 2029
- Province/Region
- Jiangsu
- Address
- Room 501, Building B11, Bionanopark, No. 218 Xinghu Street, Suzhou Industrial Park
- 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
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