Carbohydrate antigen 242 assay kit (chemiluminescence immunoassay) - NMPA Registration 粤械注准20232401549
Access comprehensive regulatory information for Carbohydrate antigen 242 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 粤械注准20232401549 and owned by Guangzhou Darui Biotechnology Co., Ltd.. The device was approved on September 15, 2023.
This page provides complete registration details including registrant information, province location (Guangdong), 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.
This kit is used for the quantitative determination of carbohydrate antigen 242 (CA242) content in human serum in vitro, and is mainly used for monitoring 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.
本试剂盒用于体外定量测定人血清中糖类抗原242（CA242）的含量，临床上主要用于胰腺癌，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 is composed of magnetic bead reagent, reaction reagent 1, and reaction reagent 2 Magnetic bead reagent: Magnetic beads coated with anti-CA242 monoclonal antibody (mouse) in Tris buffer containing protein stabilizer. Preservative: ProClin300; Reaction reagent 1: Tris buffer containing protein stabilizer. Preservative: ProClin300; Reaction reagent 2: Anti-CA242 monoclonal antibody (mouse) labeled with acridine salt in Tris buffer containing protein stabilizer. Preservative: ProClin300.
试剂盒由磁珠试剂、反应试剂1、反应试剂2组成，其中 磁珠试剂：包被抗CA242单克隆抗体（小鼠）的磁微球，于含有蛋白稳定剂的Tris缓冲液中。防腐剂：ProClin300； 反应试剂1：含有蛋白稳定剂的Tris缓冲液。防腐剂：ProClin300； 反应试剂2：标记吖啶盐的抗CA242单克隆抗体（小鼠），于含有蛋白稳定剂的Tris缓冲液中。防腐剂：ProClin300。
The kit is stored at 2~8 °C, and the reagent is placed upright during storage, and the validity period is 12 months. After the kit is opened and used, the bottle cap should be closed, and stored in the refrigerator or reagent compartment at 2~8°C with an upright position and an expiration date of 30 days.
试剂盒2～8℃储存，贮藏时试剂直立放置，有效期12个月。 试剂盒在开启使用后，盖好瓶盖，2～8℃储存于冰箱或试剂仓并保证其直立向上放置，有效期30天。