Estradiol Test Kit (Chemiluminescence Immunoassay) - NMPA Registration 苏械注准20232400707
Access comprehensive regulatory information for Estradiol Test Kit (Chemiluminescence 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20232400707 and owned by Suzhou Hokapi Biomedical Engineering Co., Ltd.. The device was approved on May 22, 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 estradiol content in human serum in vitro.
用于体外定量测定人血清中的雌二醇的含量。
Reagent R1: Biotin-labeled anti-estradiol polyclonal antibody (about 0.05 mg/L, rabbit-originated) and biotin-labeled anti-estradiol monoclonal antibody (about 0.03mg/L, sheep-born), pH about 7.4 phosphate protein buffer (about 100mmol/L), 0.1% ProClin300 preservative; Reagent R2: Estradiol derivative labeled with acridine ester (approx. 0.06 mg/L, synthetic), pH approx. 7.4 phosphate protein buffer (approx. 100 mmol/L), 0.1% ProClin300 preservative; Reagent M: Streptavidin-coated magnetic particles (approximately 0.9 mg/mL), 0.01% MIT; Calibrator 1: Contains estradiol antigen (approx. 60 pg/mL, synthetic), pH approx. 7.4 phosphate protein buffer (approx. 100mmol/L), 0.1% ProClin300 preservative; Calibrator 2: Contains estradiol antigen (about 2000 pg/mL, synthetic), pH about 7.4 phosphate protein buffer (about 100mmol/L), 0.1% ProClin300 preservative; Calibrator 3: Contains estradiol antigen (approx. 200 pg/mL, synthetic), pH approx. 7.4 phosphate protein buffer (approx. 100 mmol/L), 0.1% ProClin300 preservative. Traceability: Traceability to in-house calibrators. The reagent master curve can be obtained by scanning the label QR code.
试剂R1：含生物素标记的抗雌二醇多克隆抗体（约0.05mg/L，兔源性）和生物素标记的抗雌二醇单克隆抗体（约0.03mg/L，羊源性），pH约7.4 磷酸盐蛋白缓冲液（约100mmol/L），0.1% ProClin300防腐剂； 试剂R2：含吖啶酯标记的雌二醇衍生物 (约0.06mg/L，人工合成)，pH约7.4 磷酸盐蛋白缓冲液（约100mmol/L），0.1% ProClin300防腐剂；试剂M：含链霉亲和素包被的磁颗粒（约0.9mg/mL），0.01%MIT； 校准品1：含雌二醇抗原(约60pg/mL，人工合成)，pH约7.4磷酸盐蛋白缓冲液（约100mmol/L）， 0.1% ProClin300防腐剂； 校准品2：含雌二醇抗原(约2000pg/mL，人工合成)，pH约7.4磷酸盐蛋白缓冲液（约100mmol/L），0.1% ProClin300防腐剂； 校准品3：含雌二醇抗原(约200pg/mL，人工合成)，pH约7.4磷酸盐蛋白缓冲液（约100mmol/L），0.1% ProClin300防腐剂。 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。