Beta-human chorionic gonadotropin (β-HCG) assay kit (chemiluminescence magnetic microparticle method)
- Device class
- Class II
- Model specifications
- 100 servings/box, 200 servings/box, 100 servings; 5/box.100人份/盒、200人份/盒、100人份;5/盒。
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20242400008
- Approval date
- January 10, 2024
- Expiry date
- January 09, 2029
- Name
- Beijing Savant Biotechnology Co., Ltd.北京华科泰生物技术股份有限公司
- Province/Region
- Beijing北京
- Address
- 101-301, 302, 3rd Floor, Building 4, Yard 8, Liangshuihe 2nd Street, Beijing Economic and Technological Development Zone, Beijing (Yizhuang Group, High-end Industrial Area, Beijing Pilot Free Trade Zone)北京市北京经济技术开发区凉水河二街8号院4号楼3层101-301、302（北京自贸试验区高端产业片区亦庄组团））
- Production address
- 北京市北京经济技术开发区凉水河二街8号院4号楼3层101-302
This kit is used for the quantitative determination of beta;-human chorionic gonadotropin (beta;-HCG) in human serum in vitro.
本试剂盒用于体外定量测定人血清中beta;-人绒毛膜促性腺激素（beta;-HCG）的含量。
Calibrator (optional), quality control (optional), incubator, marker, magnetic particle reagent.
校准品（选配）、质控品（选配）、温育液、标记物、磁微粒试剂。
Store at 2 °C ~ 8 °C with an expiration date of 1
在2℃～8℃储存，有效期为1
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Beta-human chorionic gonadotropin (β-HCG) assay kit (chemiluminescence magnetic microparticle 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 京械注准20242400008 and owned by Beijing Savant Biotechnology Co., Ltd.. The device was approved on January 10, 2024.
This page provides complete registration details including registrant information, province location (Beijing), 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.