Carcinoembryonic antigen assay kit (chemiluminescence immunoassay) - NMPA Registration 苏械注准20242400352
Access comprehensive regulatory information for Carcinoembryonic antigen 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 苏械注准20242400352 and owned by Suzhou Lihe Biomedical Engineering Co., Ltd.. The device was approved on March 12, 2024.
This page provides complete registration details including registrant information, province location (Jiangsu), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
It is used for the quantitative determination of the concentration of carcinoembryonic antigen in human serum in vitro, which is mainly used for dynamic monitoring of patients with malignant tumors to assist in judging the disease process or treatment effect, and cannot be used as the basis for early diagnosis or diagnosis of malignant tumors, and cannot be used for tumor screening in the general population.
用于体外定量测定人血清中癌胚抗原的浓度，主要用于对恶性肿瘤患者进行动态监测以辅助判断疾病进程或治疗效果，不能作为恶性肿瘤早期诊断或确诊的依据，不能用于普通人群的肿瘤筛查。
Reagent 1: Biotinyl-containing anti-carcinoembryonic antigen monoclonal antibody (approximately 0.5 mg/L, murine derived), 2-(N-morpholino)ethanesulfonic acid-water buffer (containing bovine serum protein, 0.1% Proclin300); Reagent 2: Acridine ester-conjugated anti-carcinoembryonic antigen monoclonal antibody (about 0.5 mg/L, murine derived), 2-(N-morpholino)ethanesulfonic acid-water buffer (containing bovine serum protein, 0.1% Proclin300); Reagent M: Streptavidin-coated magnetic particles (about 0.3 mg/mL), treated with antiseptic; Calibrated substance: carcinoembryonic antigen (eukaryotic expression), phosphate buffered saline (bovine serum protein, 0.1% Proclin300); The concentrations were approximately 0, 2, 10, 50, 200, and 800 ng/mL, respectively, traceable to WHO standards.
试剂1：含生物素标记的抗癌胚抗原单克隆抗体(约0.5mg/L，鼠源性)，2-（N-吗啉基）乙磺酸-水缓冲液（含牛血清蛋白，0.1% Proclin300）；试剂2：含吖啶酯标记的抗癌胚抗原单克隆抗体(约0.5mg/L，鼠源性)，2-（N-吗啉基）乙磺酸-水缓冲液（含牛血清蛋白，0.1% Proclin300）；试剂M：含链霉亲和素包被的磁颗粒(约0.3mg/mL)，经防腐处理；校准品：含癌胚抗原（真核表达），磷酸盐缓冲液（含牛血清蛋白，0.1% Proclin300）；浓度分别约为：0、2、10、50、200、800ng/mL，溯源至WHO标准品。
Store at 2~8°C, valid for 18 months; The opened reagents and calibrators can be stably stored for 60 days at 2~8°C.
2～8℃保存，有效期18个月；开封的试剂及校准品，2～8℃环境下可稳定保存60天。