C-reactive Protein (CRP) Quality Control Material
- Device class
- Class II
- Model specifications
- (1)冻干粉型,水平1:0.5mL×1;水平2:0.5mL×1;水平3:0.5mL×1. (2)冻干粉型,水平1:0.2mL×1;水平2:0.2mL×1;水平3:0.2mL×1.（1）冻干粉型，水平1：0.5mL×1；水平2：0.5mL×1；水平3：0.5mL×1。 （2）冻干粉型，水平1：0.2mL×1；水平2：0.2mL×1；水平3：0.2mL×1。
- Approval department
- Guangdong Provincial Drug Administration广东省药品监督管理局
- Registration number
- 粤械注准20242401691
- Approval date
- December 19, 2024
- Expiry date
- December 18, 2029
- Name
- Guangzhou Wondfo BIOTECH Co., Ltd.广州万孚生物技术股份有限公司
- Province/Region
- Guangdong广东
- Address
- No. 8, Lizhishan Road, Science City, Huangpu District, Guangzhou广州市黄埔区科学城荔枝山路8号
- Production address
- 广州市黄埔区科学城荔枝山路8号
本产品适用于监控和评价广州万孚生物技术股份有限公司生产的C反应蛋白(CRP)测定试剂(干式荧光免疫法)、全量程C反应蛋白(hsCRP+常规CRP)测定试剂(干式荧光免疫法)检测时的质量控制.
本产品适用于监控和评价广州万孚生物技术股份有限公司生产的C反应蛋白（CRP）测定试剂（干式荧光免疫法）、全量程C反应蛋白（hsCRP+常规CRP）测定试剂（干式荧光免疫法）检测时的质量控制。
本产品为冻干粉,主要成分为C反应蛋白(CRP)抗原.
本产品为冻干粉，主要成分为C反应蛋白（CRP）抗原。
4℃～30℃密封避光保存,有效期为12个月.开盖复溶后在4℃～30℃可保存8小时,分装后可在-20℃条件下冻存28天,仅可冻融一次,不可反复冻融.
4℃～30℃密封避光保存，有效期为12个月。开盖复溶后在4℃～30℃可保存8小时，分装后可在-20℃条件下冻存28天，仅可冻融一次，不可反复冻融。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for C-reactive Protein (CRP) Quality Control Material in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20242401691 and owned by Guangzhou Wondfo BIOTECH Co., Ltd.. The device was approved on December 19, 2024.
This page provides complete registration details including registrant information, province location (Guangdong), 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.