Quantitative test kit for luteinizing hormone (LH) (colloidal gold method) - NMPA Registration 滇械注准20162400082
Access comprehensive regulatory information for Quantitative test kit for luteinizing hormone (LH) (colloidal gold 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 滇械注准20162400082 and owned by Yunnan Haoxu Biotechnology Co., Ltd.. The device was approved on September 27, 2021.
This page provides complete registration details including registrant information, province location (Yunnan), 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 in vitro quantitative detection of follicle-stimulating hormone in human serum, plasma and urine
用于体外定量检测人血清、血浆、尿液中促卵泡生成素
" 1. Follicle-stimulating hormone detection reagent: FSH monoclonal antibody and sheep anti-mouse IgG are pre-coated with colloidal gold binding pad, sample pad, and absorbent paper, respectively coated with phase nitric fiber membrane and colloidal gold labeled; 2. Other components: straw, manual, SD card; "
" 1、促卵泡生成素检测试剂：系由FSH单克隆抗体及羊抗鼠IgG分别包被于相硝酸纤维膜和胶体金标记的FSH单克隆抗体预包被于胶体金结合垫，以及样本垫、和吸水纸组成； 2、其他组成：吸管、说明书、SD卡； "
The kit is stored at 4~30 °C, and the aluminum foil bag is sealed and the validity period is 18 months; After the foil bag is unpacked, it is valid for 1 hour.
试剂盒于4~30℃保存，铝箔袋密封状态下存放，有效期为18个月；铝箔袋拆封后，有效期为1小时。