Tumor-Associated Antigen 242 Determination Reagent Kit (Chemiluminescence Immunoassay) - NMPA Registration 苏械注准20242400348
Access comprehensive regulatory information for Tumor-Associated Antigen 242 Determination Reagent 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20242400348 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 tumor-associated antigen 242 in human serum in vitro, and is clinically used for the monitoring of the efficacy of pancreatic cancer, colorectal cancer and gastrointestinal malignant tumors.
用于体外定量测定人血清中肿瘤相关抗原242的浓度，临床上用于胰腺癌、结直肠癌消化道恶性肿瘤的疗效监测，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: Biotinylated anti-tumor-associated antigen 242 monoclonal antibody (approximately 0.5 mg/L, murine derived), tris-hydroxymethyl aminomethane buffer (containing bovine serum protein, 0.1% Proclin300); Reagent 2: acridine ester-labeled anti-tumor-associated antigen 242 monoclonal antibody (about 0.5 mg/L, murine derived), tris-hydroxymethyl aminomethane buffer (containing bovine serum protein, 0.1% Proclin300); Reagent M: Streptavidin-coated magnetic particles (about 0.3 mg/mL), treated with antiseptic; Calibrated Substance: Contains tumor-associated antigen 242 (human-derived), phosphate buffered saline (contains bovine serum protein, 0.1% Proclin300); The concentrations are approximately: 0, 5, 15, 50, 150, 300U/mL, traceable to the company's internal calibrators.
试剂1：含生物素标记的抗肿瘤相关抗原242单克隆抗体(约0.5mg/L，鼠源性)，三羟甲基氨基甲烷缓冲液（含牛血清蛋白，0.1% Proclin300）；试剂2：含吖啶酯标记的抗肿瘤相关抗原242单克隆抗体(约0.5mg/L，鼠源性)，三羟甲基氨基甲烷缓冲液（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：含肿瘤相关抗原242（人源性），磷酸盐缓冲液（含牛血清蛋白，0.1% Proclin300）；浓度分别约为：0、5、15、50、150、300U/mL，溯源至企业内部校准品。
Store at 2~8°C, valid for 18 months; Opened reagents and calibrators are stable 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。