Human Epididymal Protein 4 (HE4) Assay Kit (Direct Chemiluminescence Method) - NMPA Registration 粤械注准20242400370
Access comprehensive regulatory information for Human Epididymal Protein 4 (HE4) 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20242400370 and owned by Goldsite Diagnostics Inc.. The device was approved on March 12, 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 human epididymal protein 4 (HE4) antigen in human serum and plasma samples in vitro, and is clinically used for monitoring the efficacy of ovarian cancer.
用于体外定量检测人体血清及血浆样本中的人附睾蛋白 4（HE4）抗原，临床上用于卵巢癌的疗效监测。
The kit consists of magnetic particles (M), conjugates (R1), human epididymal protein 4 (HE4) calibrator (optional), and human epididymal protein 4 (HE4) control (optional), where: Magnetic particles (M): TRIS buffer solution containing HE4 murine monoclonal antibody coated magnetic particles and surfactant and preservative Proclin 300;Conjugate (R1): PBS buffer solution containing acridine ester-labeled HE4 murine monoclonal antibody conjugate and preservative Proclin 300;Calibrator 1: PBS buffer solution containing HE4 recombinant protein, proteoprotective agent bovine serum albumin and preservative Proclin 300;Calibrator 2: Protein Protector Bovine Serum Albumin and Preservative Proclin 300 in PBS Buffer Solution, Control Level 1: PBS Buffer Solution with HE4 Recombinant Protein, Proterotectant Bovine Serum Albumin and Preservative Proclin 300, Control Level 2: PBS Buffer Solution with HE4 Recombinant Protein, Proteoprotective Agent Bovine Serum Albumin and Preservative Proclin 300
试剂盒由磁微粒（M）、结合物（R1）、人附睾蛋白4(HE4)校准品(选配)、人附睾蛋白4(HE4)质控品(选配)组成，其中： 磁微粒（M）：含HE4鼠单抗包被的磁微粒及表面活性剂、防腐剂Proclin 300的TRIS缓冲溶液；结合物（R1）：含吖啶酯标记的HE4鼠单抗结合物及防腐剂Proclin 300的PBS缓冲溶液；校准品1：含HE4重组蛋白、蛋白保护剂牛血清白蛋白及防腐剂Proclin 300的PBS缓冲溶液；校准品2：含HE4重组蛋白、蛋白保护剂牛血清白蛋白及防腐剂Proclin 300的PBS缓冲溶液；质控品 水平1：含HE4重组蛋白、蛋白保护剂牛血清白蛋白及防腐剂Proclin 300的PBS缓冲溶液；质控品 水平2：含HE4重组蛋白、蛋白保护剂牛血清白蛋白及防腐剂Proclin 300的PBS缓冲溶液
All components are stored at 2-8°C protected from light and have a shelf life of 12 months. Please use the reagent within 28 days after opening the bottle and store it at 2-8°C, and 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 controls can be stored at 2-8°C for 28 days after opening and for 24 hours at room temperature (10-30°C).
所有组分在2-8℃避光保存，保质期为12个月。 试剂开瓶后请于28天之内使用，2-8℃保存；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在2-8℃可保存28天，在室温(10-30℃)可保存24h。