Thymidine kinase 1 (TK1) cell cycle assay kit (chemiluminescence immunoassay) - NMPA Registration 湘械注准20232400792
Access comprehensive regulatory information for Thymidine kinase 1 (TK1) cell cycle assay kit (chemiluminescence immunoassay) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 湘械注准20232400792 and owned by Changsha Micron Biotechnology Co., Ltd.. The device was approved on August 18, 2023.
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This reagent is used for the quantitative determination of thymidine kinase 1 content in human serum and plasma in vitro, and is clinically used to monitor tumor proliferation.
本试剂用于体外定量测定人血清和血浆中胸苷激酶1的含量,临床上用于监测肿瘤增殖。
It consists of Reagent 1, Reagent 2, Reagent M and (optional) calibrator. Reagent 1: TK1 monoclonal antibody 1 with biotin conjugate (approx. 0.2 ug/mL), phosphate buffer (with 1% bovine serum protein, 0.1% Proclin300, pH 7.4), reagent 2: TK1 monoclonal antibody with acridine ester conjugate 2 (approx. 1 ug/mL), phosphate buffer (with 1% bovine serum protein, 0.1% Proclin300, pH 7.4), reagent M: streptavidin-coated magnetic particles (approx. 0.3 mg/mL) (Optional) Calibrator: Thymidine kinase 1, phosphate buffer (1% bovine serum protein, 0.1% Proclin300, pH 7.4), concentrations of approximately 0 pmol/L, 1 pmol/L, 2 pmol/L, 5 pmol/L, 10 pmol/L, 20 pmol/L.
由试剂1、试剂2、试剂M及（选配）校准品组成。试剂1：含生物素标记的TK1单克隆抗体1（约0.2ug/mL），磷酸盐缓冲液（含1％牛血清蛋白，0.1％ Proclin300，pH7.4）；试剂2：含吖啶酯标记的TK1单克隆抗体2（约1ug/mL），磷酸盐缓冲液（含1％牛血清蛋白，0.1％ Proclin300，pH7.4）；试剂M：含链霉亲和素包被的磁颗粒(约0.3mg/mL)，含0.1％氯乙酰胺；（选配）校准品：含胸苷激酶1，磷酸盐缓冲液（含1％牛血清蛋白，0.1％ Proclin300，pH7.4），浓度约为0pmol/L，1pmol/L，2pmol/L，5pmol/L，10pmol/L，20pmol/L。
Store at 2-8°C, valid for 18 months; The opened reagent can be stably stored for 28 days in an environment of 2~8 °C.
2-8℃环境下储存，有效期18个月；开封的试剂，2～8℃环境下可稳定保存28天。