Cystatin C detection reagent kit (latex-enhanced immune turbidity method)
- Device class
- Class II
- Model specifications
- 试剂盒规格 1 R1:1×24mL,R2:1×6mL 10 R1:4×60mL,R2:4×15mL 2 R1:1×32mL,R2:1×8mL 11 R1:4×60mL,R2:2×30mL 3 R1:1×40mL,R2:1×10mL 12 12×60 测试 4 R1:1×60mL,R2:1×15mL 13 50测试 5 R1:2×30mL,R2:1×15mL 14 100测试 6 R1:2×32mL,R2:2×8mL 15 200测试 7 R1:2×40mL,R2:2×10mL 16 400测试 8 R1:2×60mL,R2:2×15mL 17 600测试 9 R1:4×40mL,R2:2×20mL 18 800测试 校准品规格:6×0.5mL、6×1mL、6×2mL、6×3mL 质控品规格:2×0.5mL、2×1mL、2×2mL、2×3mL试剂盒规格 1 R1：1×24mL，R2：1×6mL 10 R1：4×60mL，R2：4×15mL 2 R1：1×32mL，R2：1×8mL 11 R1：4×60mL，R2：2×30mL 3 R1：1×40mL，R2：1×10mL 12 12×60 测试 4 R1：1×60mL，R2：1×15mL 13 50测试 5 R1：2×30mL，R2：1×15mL 14 100测试 6 R1：2×32mL，R2：2×8mL 15 200测试 7 R1：2×40mL，R2：2×10mL 16 400测试 8 R1：2×60mL，R2：2×15mL 17 600测试 9 R1：4×40mL，R2：2×20mL 18 800测试 校准品规格：6×0.5mL、6×1mL、6×2mL、6×3mL 质控品规格：2×0.5mL、2×1mL、2×2mL、2×3mL
- Approval department
- Anhui Provincial Drug Administration安徽省药品监督管理局
- Registration number
- 皖械注准20242400156
- Approval date
- September 21, 2024
- Expiry date
- September 20, 2029
- Name
- Anhui Iprocom Biotechnology Co., Ltd.安徽伊普诺康生物技术股份有限公司
- Province/Region
- Anhui安徽
- Address
- No. 659, Lanzhou Road, Baohe District, Hefei合肥市包河区兰州路659号
- Production address
- 合肥市包河区兰州路659号
This product is used for the quantitative determination of cystatin C content in human urine samples in vitro.
该产品用于体外定量测定人尿液样本中胱抑素C的含量。
组成 主要成分 浓度 R1 4-羟乙基哌嗪乙磺酸 聚乙二醇-20000 Proclin300 50mmol/L 5g/L 1ml/L R2 甘氨酸缓冲液 胶乳包被兔抗人胱抑素C多克隆抗体 牛血清白蛋白 Proclin300 50mmol/L 适量 5g/L 1ml/L 校准品 (选配) 4-羟乙基哌嗪乙磺酸 Proclin300 牛血清白蛋白 胱抑素C抗原 目标浓度:水平1～水平6为0mg/L、0.5mg/L、1.5mg/L、3mg/L、6mg/L、10mg/L 质控品水平一、二(选配) 4-羟乙基哌嗪乙磺酸 Proclin300 牛血清白蛋白 胱抑素C抗原 水平1目标浓度:1.16mg/L 水平2目标浓度:2.50mg/L
组成 主要成分 浓度 R1 4-羟乙基哌嗪乙磺酸 聚乙二醇-20000 Proclin300 50mmol/L 5g/L 1ml/L R2 甘氨酸缓冲液 胶乳包被兔抗人胱抑素C多克隆抗体 牛血清白蛋白 Proclin300 50mmol/L 适量 5g/L 1ml/L 校准品 （选配） 4-羟乙基哌嗪乙磺酸 Proclin300 牛血清白蛋白 胱抑素C抗原 目标浓度：水平1～水平6为0mg/L、0.5mg/L、1.5mg/L、3mg/L、6mg/L、10mg/L 质控品水平一、二（选配） 4-羟乙基哌嗪乙磺酸 Proclin300 牛血清白蛋白 胱抑素C抗原 水平1目标浓度：1.16mg/L 水平2目标浓度：2.50mg/L
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; After opening the bottle, the calibrator and quality control are stored at 2°C~8°C away from light, pay attention to volatilization, and the validity period is 14 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；开瓶后的校准品、质控品2℃～8℃避光保存，注意挥发，有效期14天。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Cystatin C detection reagent kit (latex-enhanced immune turbidity 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20242400156 and owned by Anhui Iprocom Biotechnology Co., Ltd.. The device was approved on September 21, 2024.
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.