China NMPA legacy archive 湘械注准20242401054Cardiac Troponin I (cTnI) Detection Reagent Kit (Magnetic Particle Chemiluminescence Method)
- Device class
- Class II
- Model specifications
- Type I (excluding calibrators and controls): 50 servings/box, 100 servings/box, 150 servings/box, 200 servings/box. Type II (including calibrators): 50 servings/box, 100 servings/box, 150 servings/box, 200 servings/box. Type III (including calibrators and quality controls): 50 servings/box, 100 servings/box, 150 servings/box, 200 servings/box.
- Approval department
- Hunan Provincial Drug Administration
- Registration number
- 湘械注准20242401054
- Approval date
- October 31, 2024
- Expiry date
- October 30, 2029
- Province/Region
- Hunan
- Address
- No. 101, Kangtian Road, Liuyang Economic and Technological Development Zone
- Production address
- 浏阳经济技术开发区康天路101号
用于体外定量检测血清、血浆及全血中心肌肌钙蛋白I的含量.临床上主要用于心肌梗死的辅助诊断.
用于体外定量检测血清、血浆及全血中心肌肌钙蛋白I的含量。临床上主要用于心肌梗死的辅助诊断。
产品由试剂R1、试剂R2、校准品、质控品组成.磁分离试剂R1:包被着cTnI抗体的超顺磁性微粒,0.2g/L;Tris缓冲液,50mmol/L;ProClin 300,0.5g/L;试剂R2:cTnI 抗体-吖啶酯标记物,3 mg/L;PBS 缓冲液,50mmol/L;ProClin 300,0.5 g/L;校准品:cTnI 抗原、海藻糖、PBS,水平 1:0ng/mL、水平2:(0.1-1.0)ng/mL、水平3:(20.0-30.0)ng/mL;质控品:cTnI 抗原、海藻糖、PBS,水平 1:(1.0-2.0)ng/mL、水平2:(10-20)ng/mL.
产品由试剂R1、试剂R2、校准品、质控品组成。磁分离试剂R1:包被着cTnI抗体的超顺磁性微粒,0.2g/L;Tris缓冲液,50mmol/L;ProClin 300,0.5g/L;试剂R2:cTnI 抗体-吖啶酯标记物,3 mg/L;PBS 缓冲液,50mmol/L;ProClin 300,0.5 g/L;校准品:cTnI 抗原、海藻糖、PBS,水平 1:0ng/mL、水平2:(0.1-1.0)ng/mL、水平3:(20.0-30.0)ng/mL;质控品:cTnI 抗原、海藻糖、PBS,水平 1:(1.0-2.0)ng/mL、水平2:(10-20)ng/mL。
未开封的试剂在2℃～8℃条件下保存,有效期为18个月;开封后的试剂在2℃～8℃条件下保存,有效期为1个月.未开封校准品、质控品在2℃～8℃条件下避光保存,有效期为18个月;校准品、质控品复溶后,避光2℃～8℃条件下,可稳定3天.
未开封的试剂在2℃～8℃条件下保存，有效期为18个月；开封后的试剂在2℃～8℃条件下保存，有效期为1个月。未开封校准品、质控品在2℃～8℃条件下避光保存，有效期为18个月；校准品、质控品复溶后，避光2℃～8℃条件下，可稳定3天。
- Appendix
- 产品技术要求、说明书
This static archive preserves historical registration fields and translations for Cardiac Troponin I (cTnI) Detection Reagent Kit (Magnetic Particle Chemiluminescence Method), registration 湘械注准20242401054. 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.