S100 Protein Assay Kit (Chemiluminescence Immunoassay) - NMPA Registration 粤械注准20232401667
Access comprehensive regulatory information for S100 Protein 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20232401667 and owned by Guangzhou Darui Biotechnology Co., Ltd.. The device was approved on October 11, 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 S100 protein content in human serum in vitro, and is mainly used for the treatment and monitoring of central nervous system tumors in clinical practice. 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S100蛋白的含量，临床上主要用于中枢神经系统肿瘤的治疗监测。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。
Magnetic bead reagent: Magnetic beads coated with anti-S100 monoclonal antibody (mouse) in Tris buffer (Tris, Tween 20, NaCl, BSA, ProClin 300, trehalose) containing protein stabilizers. Preservative: ProClin300. Reaction reagent 1: Tris buffer containing protein stabilizer (Tris, Tween 20, NaCl, BSA, ProClin 300, trehalose). Preservative: ProClin300 Reagent 2: Anti-S100 monoclonal antibody (mouse) labeled with acridine salt in Tris buffer (Tris, Tween 20, NaCl, BSA, ProClin 300, trehalose) containing protein stabilizer. Preservative: ProClin300.
磁珠试剂:包被抗S100单克隆抗体（小鼠）的磁微球，于含有蛋白稳定剂的Tris缓冲液（Tris、Tween 20、NaCl、BSA、ProClin 300、海藻糖）中。防腐剂：ProClin300。 反应试剂1:含有蛋白稳定剂的Tris缓冲液（Tris、Tween 20、NaCl、BSA、ProClin 300、海藻糖）。防腐剂：ProClin300 反应试剂2:标记吖啶盐的抗S100单克隆抗体（小鼠），于含有蛋白稳定剂的Tris缓冲液（Tris、Tween 20、NaCl、BSA、ProClin 300、海藻糖）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, stored at 2~8 °C and placed upright with an expiration date of 30 days. The 2~8°C transportation environment (heavy pressure should be prevented during transportation, and direct sunlight should be exposed) will not affect the performance and validity of the kit within 4 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℃储存并保证其直立向上放置，有效期30天。2～8℃运输环境（运输过程应防止重压，阳光直晒）4天内不会影响试剂盒的性能和效期。