D-Dimer Assay Reagent Kit (Latex Immunoassay Method) - NMPA Registration 苏械注准20232400837
Access comprehensive regulatory information for D-Dimer Assay Reagent Kit (Latex Immunoassay Method) 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20232400837 and owned by Ali Biotech Taizhou Co., Ltd.. The device was approved on June 14, 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。
Buffer: phosphate buffer 50mmol/L bovine serum albumin 25g/L Reagent: Latex of murine anti-human D-dimer monoclonal antibody 50μg/mL Bovine serum albumin 25g/L Tween 80 0.5ml/L calibrator (lyophilized) :D-dimer (recombinant) 5.0~10.0μg/mL phosphate buffer 50mmol/L mannitol 10g/L control (lyophilized) :D-dimer (recombinant) Level 1: 0.3~1.2μg/mL Level 2: 2.0~4.0μg/mL phosphate buffer 50mmol/L mannitol 10g/L
缓冲液:磷酸盐缓冲液 50mmol/L 牛血清白蛋白 25g/L试剂:鼠抗人D-二聚体单克隆抗体的胶乳 50μg/mL 牛血清白蛋白 25g/L 吐温80 0.5ml/L校准品（冻干）:D-二聚体（重组） 5.0~10.0μg/mL 磷酸盐缓冲液 50mmol/L 甘露醇 10g/L质控品（冻干）:D-二聚体（重组） 水平1：0.3~1.2μg/mL 水平2：2.0~4.0μg/mL 磷酸盐缓冲液 50mmol/L 甘露醇 10g/L
1. The kit is stored in the dark at 2 °C ~ 8 °C with a validity period of 18 months, and the reagent is stored in the dark at 2 °C ~ 8 °C after opening, with a validity period of 30 days. 2. Calibrators and quality control products are stored in the dark at 2 °C ~ 8 °C for 18 months, and stored in the dark at 2 °C ~ 8 °C after reconstitution, with a validity period of 6 hours. 3. The production date and expiration date are shown in the label.
1.试剂盒在2℃~8℃避光保存，有效期18个月，试剂开瓶后在2℃~8℃避光保存，有效期30天。2.校准品和质控品在2℃~8℃避光保存，有效期18个月，复溶后在2℃~8℃避光保存，有效期6小时。3.生产日期及失效日期见标签。