Gastrin-Releasing Peptide Precursor Assay Kit (Chemiluminescent Particle Immunoassay) - NMPA Registration 浙械注准20242401795
Access comprehensive regulatory information for Gastrin-Releasing Peptide Precursor Assay Kit (Chemiluminescent Particle 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 浙械注准20242401795 and owned by Ningbo Ruiyuan Biotechnology Co., Ltd.. The device was approved on September 19, 2024.
This page provides complete registration details including registrant information, province location (Zhejiang), 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 in vitro quantitative determination of the concentration of gastrin-releasing peptide precursors in human serum and plasma. It 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 is not used for tumor screening in the general population.
本试剂盒用于体外定量测定人血清和血浆中胃泌素释放肽前体的浓度。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，不用于普通人群的肿瘤筛查。
Solid phase reagents, labeling reagents, project diluents, calibrators (A-F), controls (L, H). (Please refer to the manual for details)
固相试剂、标记试剂、项目稀释液、校准品（A-F）、质控品（L、H）。（具体内容详见说明书）
The reagent can be stored upright at 2~8°C and can be stable for 12 months. The calibrators and quality controls are stored at 2~8°C, and can be stable for 12 months when stored in the dark.
试剂在2～8℃避光条件下直立保存，可稳定12个月。校准品和质控品贮存于2～8℃，避光保存可稳定12个月。