高敏肌钙蛋白T(hs-cTnT)测定试剂盒(磁微粒化学发光法) - NMPA Registration 鲁械注准20242400764
Access comprehensive regulatory information for 高敏肌钙蛋白T(hs-cTnT)测定试剂盒(磁微粒化学发光法) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 鲁械注准20242400764 and owned by Weihai Weigao BIOTECHNOLOGY Co., Ltd.. The device was approved on July 26, 2024.
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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。