Full-scale C-reactive protein (hs-CRP+ conventional CRP) assay kit (latex immunoturbidimetry)
- Device class
- Class II
- Model specifications
- R1:20mL×1 R2:5mL×1; R1:80mL×1 R2:20mL×1; R1:100mL×1 R2:25mL×1; R1:48mL×2 R2:24mL×1; R1:50mL×2 R2:25mL×1; R1:48mL×2 R2:12mL×2; R1:64mL×2 R2:16mL×2; R1:80mL×2 R2:20mL×2; R1:40mL×4 R2:20mL×2; R1:20mL×4 R2:5mL×4; R1: 64mL×6 R2: 48mL×2; 2×200 tests/box Calibrator (optional): 0.5mL×5, 0.5mL×6, 1mL×5, 1mL×6. Controls (optional): 0.5mL×1;0.5mL×2;1mL×1;1mL×2;1mL×3;1mL×6; 3mL×1;3mL×2;3mL×3;3mL×6. Note: The calibrators are divided into calibration solution-1, calibration solution-2, calibration solution-3, calibration solution-4, calibration solution-5, calibration solution-6, and the quality control products are divided into level 1 and level 2, and the specific composition of each specification is detailed in Appendix 1 of the manual.R1：20mL×1 R2：5mL×1； R1：80mL×1 R2：20mL×1； R1：100mL×1 R2：25mL×1； R1：48mL×2 R2：24mL×1； R1：50mL×2 R2：25mL×1； R1：48mL×2 R2：12mL×2； R1：64mL×2 R2：16mL×2； R1：80mL×2 R2：20mL×2； R1：40mL×4 R2：20mL×2； R1：20mL×4 R2：5mL×4； R1：64mL×6 R2：48mL×2； 2×200测试/盒 校准品（选配）：0.5mL×5；0.5mL×6；1mL×5；1mL×6。 质控品（选配）：0.5mL×1；0.5mL×2；1mL×1；1mL×2；1mL×3；1mL×6； 3mL×1；3mL×2；3mL×3；3mL×6。 注：校准品分为校准液-1、校准液-2、校准液-3、校准液-4、校准液-5、校准液-6，质控品分为水平1、水平2，各规格具体组成详见说明书附录1。
- Approval department
- Shandong Provincial Drug Administration山东省药品监督管理局
- Registration number
- 鲁械注准20232401176
- Approval date
- December 20, 2023
- Expiry date
- December 19, 2028
- Name
- Biobase Biodustry (Shandong) Co., Ltd.山东博科生物产业有限公司
- Province/Region
- Shandong山东
- Address
- Minshui Economic Development Zone, Zhangqiu District, Jinan City, Shandong Province (Shandong Brocade Industrial Park, junction of Shidong Road and Mingbu Road)山东省济南市章丘区明水经济开发区（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
It is used for in vitro quantitative determination of C-reactive protein content in human serum samples.
用于体外定量测定人血清样本中C反应蛋白的含量。
Main components: Reagent 1 (R1): trismethylolaminomethane (Tris) buffer (pH 7.0) (100mmol/L), PEG6000 (5g/L); Reagent 2 (R2): trimethylolaminomethane (Tris) buffer (pH 7.0) (100mmol/L), CRP antibody (12.8mg/mL), latex particles (10.1%); Calibrator: Calibrator-1 is purified water, and the other calibration solution is C-reactive protein dissolved in phosphate buffer (water matrix), there are 6 concentration levels, and the fixed value is batch specific, see the label for specific values. Control: C-reactive protein dissolved in phosphate buffer at 2 concentration levels, determined to be lot specific, specific target ranges are shown on the label.
主要组成成分： 试剂1（R1）：三羟甲基氨基甲烷（Tris）缓冲液（pH7.0）（100mmol/L）、PEG6000（5g/L）； 试剂2（R2）：三羟甲基氨基甲烷（Tris）缓冲液（pH7.0）（100mmol/L）、CRP抗体（12.8mg/mL）、胶乳颗粒（10.1%）； 校准品：校准液-1为纯化水，其他校准液为C反应蛋白溶于磷酸缓冲液（水基质）中，有6个浓度水平，定值为批特异，具体定值见标签。 质控品：C反应蛋白溶于磷酸缓冲液中，有2个浓度水平，定值为批特异，具体靶值范围见标签。
Store in the dark at 2 °C ~ 8 °C, and have a validity period of 12 months in a non-corrosive gas environment.
避光保存于2℃～8℃，在无腐蚀性气体环境下有效期12个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Full-scale C-reactive protein (hs-CRP+ conventional CRP) assay kit (latex immunoturbidimetry) 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20232401176 and owned by Biobase Biodustry (Shandong) Co., Ltd.. The device was approved on December 20, 2023.
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.