Small and dense LDL cholesterol determination kit (peroxidase method) - NMPA Registration 皖械注准20232400191
Access comprehensive regulatory information for Small and dense LDL cholesterol determination kit (peroxidase 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 皖械注准20232400191 and owned by Anhui Iprocom Biotechnology Co., Ltd.. The device was approved on October 19, 2023.
This page provides complete registration details including registrant information, province location (Anhui), 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.
This product is used for the quantitative determination of the content of small and dense LDL cholesterol in human serum or plasma in vitro.
该产品用于体外定量测定人血清或血浆中小而密低密度脂蛋白胆固醇的含量。
R1 GooD'S buffer 100 mmol/L Chimeric esterase 5 KU/L Magnesium-based ionic liquids 1 mL/L TOOS 2.5 mmol/L Cholesterol lipase 5 KU/L Cholesterol oxidase 10 KU/L Catalase 2500 U/L PEG6000 10 g/L Preservative: 2.5 mL/L Trehalose 100 g/L R2 GooD'S buffer 100 mmol/L PEROXIDASE 100 KU/L 4-Aminoantipyrine 2.5 mmol/L Surfactant 0.5 g/L Calibrator (optional) Bovine serum albumin, small and dense LDL cholesterol, sodium chloride, preservatives Quality Control Levels 1 & 2 (Optional) Bovine serum albumin, small and dense LDL cholesterol, sodium chloride, preservatives Note: 1. The components in different batch kits are not interchangeable, 2. The calibrators and quality controls are batch-specific, please refer to the target value list for details, and 3. The product calibrators are traceable to the working calibrators.
R1 GooD’S 缓冲液 100 mmol/L 嵌合酯酶 5 KU/L 镁基类离子液体 1 mL/L TOOS 2.5 mmol/L 胆固醇脂酶 5 KU/L 胆固醇氧化酶 10 KU/L 过氧化氢酶 2500 U/L PEG6000 10 g/L 防腐剂 2.5 mL/L 海藻糖 100 g/L R2 GooD’S 缓冲液 100 mmol/L 过氧化物酶 100 KU/L 4-氨基安替比林 2.5 mmol/L 表面活性剂 0.5 g/L 校准品（选配） 牛血清白蛋白、小而密低密度脂蛋白胆固醇、氯化钠、防腐剂 质控品水平一、二（选配） 牛血清白蛋白、小而密低密度脂蛋白胆固醇、氯化钠、防腐剂 注：1.不同批号试剂盒中各组分不可互换；2.校准品、质控品具有批特异性，详情请见靶值单；3.产品校准品溯源至工作校准品。
Unopened reagents, calibrators, and quality controls should be stored at 2°C~8°C in the dark, with an expiration date of 12 months, and no freezing; After opening the bottle, the reagent should be stored at 2°C~8°C in the dark, and the validity period is 28 days; The reconstituted calibrators and quality controls are stored at 2°C~8°C in the dark, with an expiration date of 7 days, and stored at -20°C, which can be stable for 28 days. Unopened reagents, calibrators, and quality controls should be stored at 2°C~8°C in the dark, with an expiration date of 12 months, and freezing is prohibited; After opening the bottle, the reagent should be stored at 2 °C ~ 8 °C in the dark, and the validity period is 28 days; The reconstituted calibrators and quality controls are stored at 2°C~8°C in the dark, with an expiration date of 7 days, and stored at -20°C, which can be stable for 28 days.
未开封的试剂、校准品、质控品在 2℃～8℃避光保存，有效期12个月，禁止冷冻； 开瓶后试剂在 2℃～8℃避光保存，有效期28 天； 复溶后的校准品、质控品在 2℃～8℃避光保存，有效期7 天，在-20℃保存，可稳定 28 天。未开封的试剂、校准品、质控品在2℃～8℃避光保存，有效期12个月，禁止冷冻； 开瓶后试剂在2℃～8℃避光保存，有效期28天； 复溶后的校准品、质控品在2℃～8℃避光保存，有效期7天，在-20℃保存，可稳定28天。