Progesterone Detection Kit (Chemiluminescent Immunoassay) - NMPA Registration 苏械注准20232400731
Access comprehensive regulatory information for Progesterone Detection 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 苏械注准20232400731 and owned by Suzhou Hokapi Biomedical Engineering Co., Ltd.. The device was approved on May 25, 2023.
This page provides complete registration details including registrant information, province location (Jiangsu), 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 determination of progesterone content in human serum in vitro.
用于体外定量测定人血清中的孕酮的含量。
Reagent R1: Antiprogester-labeled antiprogester-labeled antiprogester-monoclonal antibody (approx. 0.15mg/L, sheep-originated), phosphate buffer (approx. 0.1M, pH approx. 7.4, containing bovine serum albumin), 0.1% ProClin 300 antiseptic; Reagent R2: Biotin-labeled progesterone-BSA (about 0.04mg/L, chemical synthesis), phosphate buffer (about 0.1 M, pH about 7.4, containing bovine serum albumin), 0.1% ProClin300 antiseptic; Reagent M: Streptavidin-coated magnetic particles (about 0.9mg/mL), treated with antiseptic; Calibrator 1: Contains progesterone (chemical synthesis) (approx. 1 ng/mL), dehormonated human serum, 0.1% ProClin 300 antiseptic; Calibrator 2: Contains progesterone (chemical synthesis) (approx. 25 ng/mL), dehormonated human serum, 0.1% ProClin 300 antiseptic; Calibrator 3: Contains progesterone (chemical synthesis) (approx. 5 ng/mL), dehormonated human serum, 0.1% ProClin300 antiseptic Traceability: Traceability to in-house calibrators. The reagent master curve can be obtained by scanning the label QR code.
试剂R1：含吖啶酯标记的抗孕酮单克隆抗体 (约0.15mg/L，绵羊源性)，磷酸盐缓冲液（约0.1M，pH约为7.4，含牛血清白蛋白），0.1% ProClin300防腐；试剂R2：含生物素标记的孕酮-BSA(约0.04mg/L,化学合成)，磷酸盐缓冲液（约0.1M，pH约为7.4，含牛血清白蛋白），0.1% ProClin300防腐；试剂M：含链霉亲和素包被的磁颗粒（约0.9mg/mL），经防腐处理；校准品1：含孕酮（化学合成）(约1ng/mL)，去激素人血清，0.1% ProClin300防腐；校准品2：含孕酮（化学合成）(约25ng/mL)，去激素人血清，0.1% ProClin300防腐；校准品3：含孕酮（化学合成）(约5ng/mL)，去激素人血清，0.1% ProClin300防腐。溯源：溯源到企业内部校准品。试剂主曲线可通过扫描标签二维码获得。
2°C~8°C storage, valid for 18 months; The opened reagent can be stable for 60 days when stored at 2 °C ~ 8 °C.
2℃～8℃保存，有效期18个月；开封的试剂2℃～8℃保存可稳定60天。