Fibrinogen/Fibrinogen Degradation Products Determination Reagent Kit (Latex Immune Turbidimetric Assay)
- Device class
- Class II
- Model specifications
- See annex见附件
- Approval department
- Jiangsu Provincial Drug Administration江苏省药品监督管理局
- Registration number
- 苏械注准20232400868
- Approval date
- June 19, 2023
- Expiry date
- June 18, 2028
- Name
- Ali Biotech Taizhou Co., Ltd.阿里生物技术泰州有限公司
- Province/Region
- Jiangsu江苏
- Address
- Taizhou National Pharmaceutical High-tech Industrial Park, west of Taizhou Medical City, west of Tai Road, east of Building 0007, G61, East of Lujia Road, east of the first to fourth floors泰州国家医药高新技术产业园中国医药城口泰路西侧、陆家路东侧0007幢G61号一至四层东侧
- Production address
- 泰州中国医药城口泰路西侧、陆家路东侧0007幢61号一至四层东侧
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。
- Appendix
- 产品技术要求、说明书
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.
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.