Hepatitis B virus surface antigen determination reagent kit (chemiluminescence immunoassay method)
- Device class
- Class III
- Model specifications
- 30人份/盒；1×50人份/盒；60人份/盒；1×100人份/盒。
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243400760
- Approval date
- April 24, 2024
- Expiry date
- April 23, 2029
- Name
- Aikang Diagnostics Co., Ltd.深圳市爱康试剂有限公司
- Province/Region
- Guangdong广东
- Address
- 401-1201, Building 1, iKang Biotechnology, No. 66 Juqing Road, Jinsha Community, Kengzi Street, Pingshan District, Shenzhen深圳市坪山区坑梓街道金沙社区聚青路66号爱康生物1号楼401-1201
- Production address
- 深圳市坪山区坑梓街道金沙社区聚青路66号爱康生物1号楼整栋（2楼、3楼除外）
本产品用于体外定量检测人血清和（或）血浆中乙型肝炎病毒表面抗原的含量。
It is mainly composed of magnetic particles (R1), enzyme markers (R2), calibrator 1, calibrator 2, quality control 1, and quality control 2. (Please refer to the product manual for details)
主要由磁微粒（R1）、酶标记物（R2）、校准品1、校准品2、质控品1、质控品2组成。（具体内容详见产品说明书）
It can be stored in the dark at 2~8°C, and can be stored stably for 12 months.
2～8℃环境下避光储存，可稳定保存12个月。
- Changes
- 2024-04-28 变更注册证载明的生产地址由深圳市龙华区观澜街道新澜社区观光路1303号鸿信工业园3号厂房501；1号厂房501;变更为：深圳市坪山区坑梓街道金沙社区聚青路66号爱康生物1号楼整栋（2楼、3楼除外）
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Hepatitis B virus surface antigen determination reagent kit (chemiluminescence immunoassay method) in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243400760 and owned by Aikang Diagnostics Co., Ltd.. The device was approved on April 24, 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.