Hemoglobin A1c (HbA1c) Quantitative Test Kit (Colloidal Gold Method)
- Device class
- Class II
- Model specifications
- "1 serving/box, 10 servings/box, 25 servings/box, 50 servings/box. Glycated hemoglobin (HbA1c) quantitative control: 1ml (optional) ""1人份/盒，10人份/盒，25人份/盒，50人份/盒。 糖化血红蛋白（HbA1c）定量质控品：1ml(可选购) "
- Approval department
- Yunnan Food and Drug Administration云南省食品药品监督管理局
- Registration number
- 滇械注准20162400087
- Approval date
- September 26, 2021
- Expiry date
- September 25, 2026
- Name
- Yunnan Haoxu Biotechnology Co., Ltd.云南昊戌生物科技有限公司
- Province/Region
- Yunnan云南
- Address
- Production workshop on the 3rd floor of No. 4 Industrial Standard Workshop of Block A6-2, High-tech Industrial Base, Majinpu Township, High-tech Industrial Base, Kunming City, Yunnan Province云南省昆明市高新区马金铺乡新城高新技术产业基地A6-2地块4号工业标准厂房3层生产车间
- Production address
- 云南省昆明市高新区马金铺乡新城高新技术产业基地A6-2地块4号工业标准厂房3层生产车间
For in vitro quantitative detection of glycated hemoglobin in human blood
用于体外定量检测人血液中糖化血红蛋白
"1. Glycated hemoglobin (HbA1c) quantitative detection kit: it is composed of HbA1C monoclonal antibody and sheep anti-mouse IgG pre-coated with colloidal gold binding pad, sample pad, and absorbent paper; 2. Other components: straw, instruction manual, SD "
"1、糖化血红蛋白（HbA1c）定量检测试剂盒：系由HbA1C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HbA1c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 "
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。
Access comprehensive regulatory information for Hemoglobin A1c (HbA1c) Quantitative Test Kit (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20162400087 and owned by Yunnan Haoxu Biotechnology Co., Ltd.. The device was approved on September 26, 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.