S100-β蛋白测定试剂盒(化学发光免疫分析法)
- Device class
- Class II
- Model specifications
- 24 tests/box, 36 tests/box, 48 tests/box, 50 tests/box, 72 tests/box, 96 tests/box, 100 tests/box, 200 tests/box
- Approval department
- Jiangsu Provincial Drug Administration
- Registration number
- 苏械注准20242401186
- Approval date
- May 28, 2024
- Expiry date
- May 27, 2029
- Province/Region
- Jiangsu
- Address
- Taizhou City, China Medicine City Kou Tai Road, east side of G59 Building No. 62 west half of the west side of the first to fourth floors
- Production address
- 泰州市中国医药城口泰路西侧、陆家路东侧G59幢62号西半侧一至四层
用于体外定量检测人血清中的S100-β蛋白(S100-β)含量。
1.试剂盒由校准品、质控品、 抗试剂、磁微粒组成校准品:有高、低2个不同浓度,分别添加了不同量S100重组抗原(大肠杆菌),含约5%牛血清白蛋白(BSA)、0.05% Proclin300的0.05M Tirs缓冲液,约pH7.5,校准品浓度分别约为1.5μg /L、16μg /L;质控品:有高、低2个不同浓度,分别添加了不同量S100重组抗原(大肠杆菌),含约5%牛血清白蛋白(BSA)、0.05% Proclin300的0.05M Tirs缓冲液,约pH7.5,质控品浓度分别约为1.5μg /L、16μg /L;抗试剂A:异硫氰酸荧光素(FITC)标记的鼠抗人S100蛋白单克隆抗体,浓度约2μg/mL,含约0.5%牛血清白蛋白(BSA)的0.1M Tris缓冲液,约pH8.0;抗试剂B:碱性磷酸酶(AP)标记的鼠抗人S100蛋白单克隆抗体,浓度约1μg/mL,含0.5%牛血清白蛋白(BSA)的0.1M Tris冲液,pH8.0;磁微粒试剂:磁微粒与羊抗FITC多克隆抗体偶联物,浓度约1mg/mL,含约0.5%BSA、0.1% Proclin300的0.05MTris缓冲液,约pH8.0;注:不同批号试剂盒中各组分不可互换;
1.2~8℃密闭保存,有效期为18个月;2. 液体试剂开瓶后应在1个月内使用,2~8℃保存;3.校准品、质控品复溶后应在7天内使用,2~8℃保存。4.生产日期和使用期限请见产品标签。
- Appendix
- 产品技术要求、说明书
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