高敏肌钙蛋白T(hs-cTnT)测定试剂盒(磁微粒化学发光法)
- Device class
- Class II
- Model specifications
- 1×50 servings/box, 2×50 servings/box, 1×100 servings/box, 2×100 servings/box.
- Approval department
- Shandong Provincial Drug Administration
- Registration number
- 鲁械注准20242400764
- Approval date
- July 26, 2024
- Expiry date
- July 25, 2029
- Province/Region
- Shandong
- Address
- No. 1-4, Weigao Road, Torch High-tech Industrial Development Zone, Weihai City, Shandong Province
- Production address
- 山东省威海临港经济技术开发区棋山路566号
It is used for in vitro quantitative detection of cardiac troponin T content in human serum/plasma.
用于体外定量检测人血清/血浆中的心肌肌钙蛋白T含量。
Troponin T magnetic particles: Liquid containing 1 mg of magnetic particles labeled with 20 μg of cTnT antibody; Troponin T tracer conjugate: solution containing 10 mol acridine ester labeled with 1 mol cTnT antibody; Calibrator 1: A buffer solution containing a low concentration of cTnT pure product, the concentration is batch-specific, and its concentration is obtained by scanning the label, and the concentration value is not less than 14ng/L; Calibrator 2: A buffer solution containing a high concentration of pure cTnT, the concentration is batch-specific, and its concentration is obtained by scanning the label, and the concentration value is not less than 1000ng/L; Control 1: Buffer solution containing low concentrations of pure cTnT, with batch-specific concentrations, and the concentration range of the control is shown on the label of the corresponding lot number. Control 2: Buffer solution containing a high concentration of pure cTnT, the concentration is batch-specific, and the concentration range of the control is shown on the label of the corresponding lot number. The product performance index is shown in the product technical requirements.
测肌钙蛋白T磁微粒:含有1mg磁微粒标记20μg cTnT抗体的液体; 测肌钙蛋白T示踪结合物:含有10mol吖啶酯标记1mol cTnT抗体的溶液; 校准品1:含有低浓度cTnT纯品的缓冲溶液,浓度有批特异性,其浓度通过扫描标签获得,浓度值不低于14ng/L; 校准品2:含有高浓度cTnT纯品的缓冲溶液,浓度有批特异性,其浓度通过扫描标签获得,浓度值不低于1000ng/L; 质控品1:含有低浓度cTnT纯品的缓冲溶液,浓度有批特异性,质控品浓度范围见对应批号的标签。 质控品2:含有高浓度cTnT纯品的缓冲溶液,浓度有批特异性,质控品浓度范围见对应批号的标签。 产品性能指标见产品技术要求。
Store at 2~8°C in the dark, valid for 14 months.
2~8℃避光保存,有效期14个月。
- Appendix
- 产品技术要求、说明书
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