Full Range C-reactive Protein Detection Test Kit (Immunoturbidimetry Method)
- Device class
- Class II
- Model specifications
- Model: OGS-223, Packing specifications: 1 person/bag, 5 servings/box, 10 servings/box, 20 servings/box, 30 servings/box, 40 servings/box, 50 servings/box; Full scale C-reactive protein control (optional): Model: OGC-223, Packaging specifications: 1 bottle/box (control 1 or control 2), 2 bottles/box (1 bottle of control 1 and 1 bottle of control 2), 4 bottles/box (2 bottles of control 1 and 2 bottles of control 2).型号：OGS-223, 包装规格：1人份/袋，5人份/盒，10人份/盒，20人份/盒，30人份/盒，40人份/盒，50人份/盒； 全量程C-反应蛋白质控品（选配）：型号：OGC-223， 包装规格：1瓶/盒（质控品1或质控品2），2瓶/盒（1瓶质控品1和1瓶质控品2），4瓶/盒（2瓶质控品1和2瓶质控品2）。
- Approval department
- Zhejiang Provincial Drug Administration浙江省药品监督管理局
- Registration number
- 浙械注准20232401232
- Approval date
- April 24, 2023
- Expiry date
- April 23, 2028
- Name
- Acon Biotech (Hangzhou) Co., Ltd.艾康生物技术（杭州）有限公司
- Province/Region
- chekiang浙江
- Address
- No. 210, Zhenzhong Road, West Lake District, Hangzhou杭州市西湖区振中路210号
- Production address
- 杭州市西湖区振中路210号；杭州市临安区开源街8号3幢（仓库地址）
This kit is used for in vitro quantitative detection of C-reactive protein concentration in human capillary whole blood, venous whole blood, serum or plasma.
本试剂盒用于体外定量检测人体毛细血管全血、静脉全血、血清或血浆中的C-反应蛋白浓度。
The kit contains a plastic cartridge, sampler, reaction reagent, and QR code with calibration curve; The quality control consists of control 1, control 2, complex solution, dropper cap and quality control information box. (Please refer to the manual for details)
试剂盒包含塑料盒、取样器、反应试剂和二维码（内含校准曲线）； 质控品由质控品1、质控品2、复溶液、滴管盖和质控信息盒组成。 （具体内容详见说明书）
The kit is stored at 2 °C ~ 30 °C and the validity period is 24 months; The quality control products are stored at 2 °C ~ 8 °C for 24 months.
试剂盒2℃～30℃保存，有效期为24个月；质控品在2℃～8℃条件下保存，有效期为24个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Full Range C-reactive Protein Detection Test Kit (Immunoturbidimetry 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 浙械注准20232401232 and owned by Acon Biotech (Hangzhou) Co., Ltd.. The device was approved on April 24, 2023.
This page provides complete registration details including registrant information, province location (chekiang), 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.