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C-reactive Protein (CRP) Quality Control Material - NMPA Registration 闽械注准20242400099

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 闽械注准20242400099 and owned by InTec Products, INC.. The device was approved on July 02, 2024.

This page provides complete registration details including registrant information, province location (Fujian), 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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NMPA Official Data
Class II
闽械注准20242400099
C-reactive Protein (CRP) Quality Control Material
C反应蛋白(CRP)质控品
NMPA Registration Number: 闽械注准20242400099
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Pricing
Intended Use
English

Used with our full-scale C-reactive protein and C-reactive protein assay kits for in-house quality control of full-scale C-reactive protein and C-reactive protein detection systems.

中文

与本公司生产的全量程C反应蛋白和C反应蛋白测定试剂盒配套使用,用于全量程C反应蛋白和C反应蛋白检测系统的室内质量控制。.

Device Classification
Device Class
Class II
Model Specifications
Level 1: 1mL×1 Level 1: 1mL×3 Level 2: 1mL×1 Level 2: 1mL×3 Level 1: 1mL×1, Level 2: 1mL×1 Level 1: 1mL×3, Level 2: 1mL×3
水平1:1mL×1 水平1:1mL×3 水平2:1mL×1 水平2:1mL×3 水平1:1mL×1,水平2:1mL×1 水平1:1mL×3,水平2:1mL×3
Approval Department
Fujian Provincial Drug Administration
福建省药品监督管理局
Registration Information
Registration Number
闽械注准20242400099
Approval Date
July 02, 2024
Expiry Date
July 01, 2029
Registrant
Name
InTec Products, INC.
英科新创(厦门)科技股份有限公司
Province/Region
Fujian
福建
Address
No. 332, Xinguang Road, Xiamen Xinyang Industrial Zone, Haicang
厦门市海沧新阳工业区新光路332号
Production Facility
Production Address
厦门市海沧新阳工业区新光路332号;厦门市海沧新阳工业区翁角路308号8号和51号厂房
Structure and Composition
English

This product is made with the addition of C-reactive protein, preservatives, etc. to a phosphate-buffered saline matrix. The main components of biological origin concentration range C-reactive protein E. coli level 1:5 mg/L~25mg/L Level 2: 25 mg/L~50mg/L .

中文

本产品是在磷酸盐缓冲液基质中添加C反应蛋白、防腐剂等。 主要成分 生物学来源 浓度范围 C反应蛋白 大肠杆菌 水平1:5 mg/L~25mg/L 水平2:25 mg/L~50mg/L .

Storage Conditions and Expiration
English

The original packaging control is stored in a closed and dark area under the condition of 2°C~8°C, and the expiration date is 18 months.

中文

原包装质控品在2℃~8℃条件下密闭避光贮存,有效期18个月。

Additional Information
Appendix
产品技术要求、说明书