Anti-Cyclic Guanosine Monophosphate Peptide Antibody Detection Test Kit (Latex-Enhanced Immuno-Turbidimetric Method) - NMPA Registration 渝械注准20162400163
Access comprehensive regulatory information for Anti-Cyclic Guanosine Monophosphate Peptide Antibody Detection Test Kit (Latex-Enhanced Immuno-Turbidimetric 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 渝械注准20162400163 and owned by Chongqing Zhongyuan BIO-TECHNOLOGY Co., Ltd.. The device was approved on October 15, 2021.
This page provides complete registration details including registrant information, province location (Chongqing), 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 to detect the content of anti-cyclic citrullinated peptide (CCP) antibodies in human samples (serum), and is mainly used to assist the diagnosis of rheumatoid arthritis (RA).
用于检测人体样本（血清）中抗环瓜氨酸肽（CCP）抗体的含量，主要用于类风湿性关节炎（RA）的辅助诊断。
Reagent R1 Phosphate buffer 50 mmol/L Reagent R2 Glycine buffer 50 mmol/L Cyclic citrullinated peptide antigen latex granules Calibrator (optional) 0.30% Sheep anti-human CCP antibody Quality control (optional) The labeled value is shown in the bottle label Sheep anti-human CCP antibody The labeled value is shown in the bottle label Anti-cyclic citrullinated peptide (CCP) antibody detection systems are traceable to corporate standards. Components in different lot sizes are not interchangeable.
试剂R1 磷酸盐缓冲液 50 mmol/L 试剂R2 甘氨酸缓冲液 50 mmol/L 环瓜氨酸肽抗原胶乳颗粒 校准品（选配） 0.30% 羊抗人CCP抗体 质控品（选配） 标示值见瓶签 羊抗人CCP抗体 标示值见瓶签 抗环瓜氨酸肽（CCP）抗体检测系统可溯源至企业标准。 不同批号试剂盒中各组份不能互换。
1. The kit should be stored at 2~8 °C in the dark, not frozen, and the product validity period is 12 months. 2. After opening, store at 2~8 °C, can be stable for 10 days, please close the bottle when not in use to avoid pollution.
1. 试剂盒应2～8℃避光贮存，不得冻存，产品有效期为12个月。 2. 开封后，在2～8℃贮存，可稳定10天，不使用时请盖好瓶盖，避免污染。