Cancer Antigen 72-4 (CA72-4) Assay Kit (Direct Chemiluminescence Method) - NMPA Registration 粤械注准20242400520
Access comprehensive regulatory information for Cancer Antigen 72-4 (CA72-4) 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20242400520 and owned by Goldsite Diagnostics Inc.. The device was approved on April 15, 2024.
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.
It is used for the quantitative detection of cancer antigen 72-4 (CA72-4) in human serum and plasma samples in vitro, and is mainly used for the monitoring of the efficacy of malignant tumors such as the gastrointestinal system in clinical practice.
用于体外定量检测人血清、血浆样本中癌抗原 72-4（CA72-4），临床上主要用于胃肠系统等恶性肿瘤的疗效监测。
It consists of magnetic particles (M), conjugate (R1), cancer antigen 72-4 (CA72-4) calibrator (optional), and cancer antigen 72-4 (CA72-4) control (optional).
由磁微粒（M）、结合物（R1）、癌抗原72-4（CA72-4）校准品（选配）、癌抗原72-4（CA72-4）质控品（选配）组成。
All components are stored at 2~8°C, forbidden to freeze, and the shelf life is 12 months. Please use the reagent within 28 days after opening the bottle, store 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 QCs 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。