Retinol-binding protein assay kit (immune turbidimetry)
- Device class
- Class II
- Model specifications
- R1:60mL×2 R2:20mL×2;R1:18mL×4 R2:6mL×4; R1:18mL×1 R2:6mL×1;R1:60mL×1 R2:20mL×1; R1:40mL×3 R2:20mL×2;R1:48mL×2 R2:16mL×2; R1:45mL×2 R2:15mL×2;R1:90mL×1 R2:30mL×1; R1:60mL×5 R2:20mL×5;2×200测试/盒(120mL) ; 校准品(选配):1 mL×1.1 mL×2.1 mL×5; 质控品(选配):1 mL×1.1 mL×2.R1：60mL×2 R2:20mL×2；R1：18mL×4 R2:6mL×4； R1：18mL×1 R2:6mL×1；R1：60mL×1 R2:20mL×1； R1：40mL×3 R2:20mL×2；R1：48mL×2 R2:16mL×2； R1：45mL×2 R2:15mL×2；R1：90mL×1 R2:30mL×1； R1：60mL×5 R2:20mL×5；2×200测试/盒(120mL) ； 校准品（选配）：1 mL×1，1 mL×2，1 mL×5； 质控品（选配）：1 mL×1，1 mL×2。
- Approval department
- Shandong Provincial Drug Administration山东省药品监督管理局
- Registration number
- 鲁械注准20162400026
- Approval date
- August 04, 2022
- Expiry date
- December 17, 2025
- Name
- Biobase Biodustry (Shandong) Co., Ltd.山东博科生物产业有限公司
- Province/Region
- Shandong山东
- Address
- Jinan Zhangqiu Mingshui Economic Development Zone is bordered by Shandong Brocade Industrial Park via Shidong Road and Mingbu Road济南市章丘明水经济开发区经十东路与明埠路交界山东博科产业园
- Production address
- 济南市章丘明水经济开发区经十东路与明埠路交界山东博科产业园
Intended Use: For in vitro quantitative detection of retinol-binding protein (RBP) content in human serum.
预期用途：用于体外定量检测人体血清中视黄醇结合蛋白（RBP）的含量。
Main components: Reagent 1 (R1): phosphate buffer (pH 6.8) (53 mmol/L); Reagent 2 (R2): Sheep anti-human RBP antibody (0.4 w/v%). Calibrator (optional): Retinol-binding protein is dissolved in buffer, its values are shown on the label. Controls (optional): Retinol-binding proteins are dissolved in buffer, and their values are shown on the label.
主要组成成分： 试剂1（R1）: 磷酸盐缓冲液（pH 6.8）（53mmol/L）；试剂2（R2）: 羊抗人RBP抗体（0.4w/v%）。 校准品（选配）：视黄醇结合蛋白溶于缓冲液中，其定值见标签。 质控品（选配）：视黄醇结合蛋白溶于缓冲液中，其定值见标签。
The kit is sealed and protected from light in an environment of 2 °C ~ 8 °C without corrosive gas, and the validity period is 12 months.
试剂盒在2℃～8℃、无腐蚀性气体的环境中密封避光保存，有效期为12个月。
Access comprehensive regulatory information for Retinol-binding protein assay kit (immune turbidimetry) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 鲁械注准20162400026 and owned by Biobase Biodustry (Shandong) Co., Ltd.. The device was approved on August 04, 2022.
This page provides complete registration details including registrant information, province location (Shandong), 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.