Carbohydrate Antigen 242 (CA242) Assay Kit (Direct Chemiluminescence Method) - NMPA Registration 粤械注准20242400287
Access comprehensive regulatory information for Carbohydrate Antigen 242 (CA242) Assay Kit (Direct Chemiluminescence Method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20242400287 and owned by Goldsite Diagnostics Inc.. The device was approved on February 19, 2024.
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It is used for the quantitative detection of carbohydrate antigen 242 (CA242) in human serum and plasma samples in vitro, and is clinically used for the monitoring of the efficacy of pancreatic cancer, colorectal cancer and other gastrointestinal malignant tumors. It 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.
用于体外定量检测人血清、血浆样本中糖类抗原242（CA242），临床上用于胰腺癌、结直肠癌等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。
The kit consists of magnetic particles (M), conjugates (R1), carbohydrate antigen 242 (CA242) calibrator (optional), and carbohydrate antigen 242 (CA242) control (optional), where: Magnetic particles (M): phosphate buffer containing murine anti-CA242 monoclonal antibody-coated magnetic particles, 3% BSA, 0.1% preservative (Proclin300); Conjugate (R1): phosphate buffer containing acridine ester conjugate, murine anti-CA242 monoclonal antibody, 0.1% preservative (Proclin300); Calibrator 1 and Calibrator 2: Tris buffer containing human CA242 antigen, 2% BSA and 0.05% preservative (Proclin300); Control Level 1, Level 2: Tris buffer containing human CA242 antigen, 2% BSA, and 0.05% preservative (Proclin300).
试剂盒由磁微粒（M）、结合物（R1）、糖类抗原242(CA242)校准品（选配）、糖类抗原242(CA242)质控品（选配）组成，其中： 磁微粒（M）：含鼠抗CA242单克隆抗体包被的磁微粒、3%BSA、0.1%防腐剂（Proclin300）的磷酸盐缓冲液； 结合物（R1）：含鼠抗CA242单克隆抗体吖啶酯结合物、0.1%防腐剂（Proclin300）的磷酸盐缓冲液； 校准品1、校准品2：含人源CA242抗原、2%BSA及0.05%防腐剂（Proclin300）的Tris缓冲液； 质控品水平1、水平2：含人源CA242抗原、2%BSA及0.05%防腐剂（Proclin300）的Tris缓冲液。
All components are stored at 2-8 °C, do not freeze, and have a shelf life of 12 months. Please use the reagent within 28 days after opening the bottle, store it at 2-8 °C, and it is strictly forbidden to freeze; When the reagent tray of the instrument is in a normal refrigeration state (2-8 °C), the reagent can be stored in the machine for 28 days. Calibrators and controls can be stored at room temperature (15-30°C) after opening for 8 hours and at 2-8°C for 7 days.
所有组分在2-8℃保存，禁止冷冻，保质期为12个月。 试剂开瓶后请于28天之内使用，2-8℃保存，严禁冷冻； 仪器试剂盘制冷状态正常时（2-8℃），试剂在机可保存28天。 校准品和质控品开瓶后室温（15-30℃）保存，可保存8小时，在2-8℃保存，可保存7天。