Testosterone Test Kit (Chemiluminescent Immunoassay) - NMPA Registration 湘械注准20222400069
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.
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。