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血清淀粉样蛋白A(SAA)/C反应蛋白(CRP)复合质控品 - NMPA Registration 粤械注准20242401689

Access comprehensive regulatory information for 血清淀粉样蛋白A(SAA)/C反应蛋白(CRP)复合质控品 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20242401689 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.

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Class II
粤械注准20242401689
血清淀粉样蛋白A(SAA)/C反应蛋白(CRP)复合质控品
血清淀粉样蛋白A(SAA)/C反应蛋白(CRP)复合质控品
NMPA Registration Number: 粤械注准20242401689
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Pricing
Intended Use
English

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血清淀粉样蛋白A(SAA)/C反应蛋白(CRP)联检试剂(干式荧光免疫法)检测时的质量控制.

中文

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血清淀粉样蛋白A(SAA)/C反应蛋白(CRP)联检试剂(干式荧光免疫法)检测时的质量控制。

Device Classification
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 Information
Registration Number
粤械注准20242401689
Approval Date
December 19, 2024
Expiry Date
December 18, 2029
Registrant
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 Facility
Production Address
广州市黄埔区科学城荔枝山路8号
Structure and Composition
English

本产品为冻干粉,主要成分为血清淀粉样蛋白A(SAA)抗原与C反应蛋白(CRP)抗原.

中文

本产品为冻干粉,主要成分为血清淀粉样蛋白A(SAA)抗原与C反应蛋白(CRP)抗原。

Storage Conditions and Expiration
English

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.

中文

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。

Additional Information
Appendix
产品技术要求、说明书