Fibrinogen/Fibrinogen Degradation Products Determination Reagent Kit (Latex Immune Turbidimetric Assay) - NMPA Registration 苏械注准20232400868
Access comprehensive regulatory information for Fibrinogen/Fibrinogen Degradation Products Determination Reagent Kit (Latex Immune Turbidimetric Assay) 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20232400868 and owned by Ali Biotech Taizhou Co., Ltd.. The device was approved on June 19, 2023.
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For the in vitro quantitative determination of fibrin/fibrinogen degradation products (FDP) in human plasma.
用于体外定量测定人血浆中纤维蛋白/纤维蛋白原降解产物（FDP）的含量。
Buffer: Trimethylolaminomethane-hydrochloride buffer 100mmoL/L bovine serum albumin 30g/L Reagent: Latex particles of murine anti-human fibrin/fibrinogen degradation product (FDP) monoclonal antibody 0.1% calibrator (lyophilized): fibrin/fibrinogen degradation product (recombinant protein) 70~120μg/mL phosphate buffer 50mmol/L bovine serum albumin 30g/L control (lyophilized): fibrin/ Fibrinogen degradation products (recombinant protein) level 1: 3~9μg/mL level 2: 12~30μg/mL phosphate buffer 50mmol/L bovine serum albumin 30g/L
缓冲液:三羟甲基氨基甲烷-盐酸缓冲液100mmoL/L 牛血清白蛋白 30g/L试剂:鼠抗人纤维蛋白/纤维蛋白原降解产物（FDP）单克隆抗体的胶乳颗粒 0.1%校准品（冻干）:纤维蛋白/纤维蛋白原降解产物（重组蛋白） 70~120μg/mL 磷酸盐缓冲液 50mmol/L 牛血清白蛋白 30g/L质控品（冻干）:纤维蛋白/纤维蛋白原降解产物（重组蛋白） 水平1：3~9μg/mL水平2：12~30μg/mL 磷酸盐缓冲液 50mmol/L 牛血清白蛋白 30g/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。