China NMPA legacy archive 湘械注准20252400013α-突触核蛋白(α-synuclein)测定试剂盒（磁微粒化学发光法）
- 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 calibrator): 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20252400013
- Approval date
- January 03, 2025
- Expiry date
- January 02, 2030
- 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
用于体外定量检测人体血清和血浆样本中的α-突触核蛋白含量。
产品由试剂R1、试剂R2、校准品、质控品组成。磁分离试剂R1:包被有α-突触核蛋白抗体的磁性微粒(约0.07μg/mL);ProClin 300,约 0.5g/L;试剂 R2:α-突触核蛋白抗体-吖啶酯标记物,约3μg/mL;ProClin 300,约 0.5 g/L;校准品: α-突触核蛋白抗原、PBS,水平1:0 pg/mL、水平2:(300-1500)pg/mL、水平3:(5000-20000)pg/mL;质控品:α-突触核蛋白抗原、PBS, 水平 1:(300-1500)pg/mL、水平2:(5000-20000)pg/mL。
未开封的试剂 2℃～8℃条件下避光保存，有效期为18个月；开封后，2℃～8℃避光保存可稳定30天。未开封的校准品、质控品 2℃～8℃条件下避光保存，有效期为18个月；开封后，校准品、质控品复溶后2℃～8℃条件下保存，24小时内使用。
- Appendix
- 产品技术要求、说明书
This static archive preserves historical registration fields and translations for α-突触核蛋白(α-synuclein)测定试剂盒（磁微粒化学发光法）, registration 湘械注准20252400013. It does not establish current authorization or complete current product details.
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