Testosterone Test Kit (Chemiluminescent Immunoassay)
- Device class
- Class II
- Model specifications
- 100 servings/box, 200 servings/box100人份/盒、200人份/盒
- Approval department
- Hunan Provincial Drug Administration湖南省药品监督管理局
- Registration number
- 湘械注准20222400069
- Approval date
- March 25, 2022
- Expiry date
- January 17, 2027
- Name
- Hunan Huaxi Pharmaceutical Co., Ltd.湖南华曦医药有限公司
- Province/Region
- Hunan湖南
- Address
- No. 18 Xiangtai Road, Liuyang Economic and Technological Development Zone, Changsha E Center Phase I, Building A1, 2nd Floor, 2nd Floor Plant 201, 202浏阳经济技术开发区湘台路18号长沙E中心一期A1栋2层201、202号厂房
- Production address
- 浏阳经济技术开发区湘台路18号长沙E中心一期A1栋2层201、202号厂房
It is used for the quantitative detection of testosterone concentration in human serum in vitro.
用于体外定量检测人血清中睾酮的浓度。
Reagent 1: Biotin-labeled testosterone (approx. 0.5 mg/L, chemically synthesized), phosphate buffer (containing 1% bovine serum protein, 0.1% Proclin300, PH7.4); Reagent 2: Acridine-labeled testosterone monoclonal antibody (c., c., rabbit-derived), phosphate buffer (containing 1% bovine serum protein, 0.1% Proclin300, PH7.4); Reagent M: Streptavidin-coated magnetic particles (about 0.3mg/mL), treated with antiseptic; Series calibrators: containing testosterone (human), phosphate buffer (containing 1% bovine serum protein, 0.1% Proclin300, PH7.4); The concentrations are about 0, 50, 100, 300, 600, 1500ng/dL, respectively.
试剂 1:含生物素标记的睾酮(约 0.5mg/L,化学合成),磷酸盐缓冲液(含 1%牛血清蛋白,0.1%Proclin300,PH7.4);试剂 2:含吖啶酯标记的睾酮单克隆抗体 (约 0.5mg/L,兔源性),磷酸盐缓冲液(含 1%牛血清蛋白,0.1%Proclin300,PH7.4);试剂 M:含链霉亲和素包被的磁颗粒(约0.3mg/mL),经防腐处理;系列校准品:含睾酮(人源性),磷酸盐缓冲液 (含 1%牛血清蛋白,0.1%Proclin300,PH7.4);浓度分别约为:0、50、100、300、600、1500ng/dL。
Store at 2~8°C with a validity period of 18 months; The opened reagents and calibrators can be stably stored for 60 days at 2~8°C.
2～8℃环境下储存，有效期18个月；开封的试剂及校准品，2～8℃环境下可稳定保存60天。
Access comprehensive regulatory information for Testosterone Test Kit (Chemiluminescent Immunoassay) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 湘械注准20222400069 and owned by Hunan Huaxi Pharmaceutical Co., Ltd.. The device was approved on March 25, 2022.
This page provides complete registration details including registrant information, province location (Hunan), 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.