D-dimer Assay Kit (Chemiluminescence Immunoassay) - NMPA Registration 苏械注准20232400706
Access comprehensive regulatory information for D-dimer Assay 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20232400706 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.
For the quantitative determination of D-dimer content in human plasma in vitro.
用于体外定量测定人血浆中D-二聚体的含量。
Reagent R1: Biotin-labeled D-dimer monoclonal antibody 1 (about 1500 ng/mL, murine), pH about 6.0 MES protein buffer (about 0.05M), 0.1% ProClin300 anticorrosion; Reagent R2: Acridine-labeled D-dimer monoclonal antibody 2 (about 1500 ng/mL, murine), pH about 5.25 sodium citrate protein buffer (about 0.1 M), 0.1% ProClin 300 antiseptic; Reagent M: Streptavidin-coated magnetic particles (about 0.9mg/mL), treated with antiseptic; Calibrator 1: Contains humanized D-dimer antigen (approx. 1.6 μg/mL (FEU)), bovine serum, 0.1% ProClin 300, lyophilized; Calibrator 2: Contains humanized D-dimer antigen (approx. 20 μg/mL (FEU)), bovine serum, 0.1% ProClin 300, lyophilized; Calibrator 3: Contains human D-dimer antigen (approx. 5 μg/mL (FEU)), bovine serum, 0.1% ProClin 300, lyophilized. The main curve can be obtained by scanning the label QR code.
试剂R1：含生物素标记的D-二聚体单克隆抗体1(约1500ng/mL，鼠源性)，pH约6.0 MES蛋白缓冲液（约0.05M），0.1%ProClin300防腐； 试剂R2：含吖啶酯标记的D-二聚体单克隆抗体2(约1500ng/mL，鼠源性)，pH约5.25 柠檬酸柠檬酸钠蛋白缓冲液（约0.1M），0.1% ProClin 300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：含人源性的D-二聚体抗原(约1.6μg/mL（FEU）)，牛血清，0.1% ProClin 300，冻干品；校准品2：含人源性的D-二聚体抗原(约20μg/mL（FEU）)，牛血清，0.1% ProClin 300，冻干品； 校准品3：含人源性的D-二聚体抗原(约5μg/mL（FEU）)，牛血清，0.1% ProClin 300，冻干品。 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 is stored at 2 °C ~ 8 °C and can be stable for 60 days; Calibrator for reconstitution: stored at 2 °C ~ 8 °C, stable for 6 hours; Store at ≤-15°C and stabilize for 60 days.
2℃～8℃保存，有效期18个月； 开封的试剂2℃～8℃保存，可稳定60天； 复溶的校准品：2℃～8℃保存，可稳定6小时；≤-15℃保存，可稳定60天。