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Cardiac troponin I detection kit (fluorescence immunoassay chromatography method) - NMPA Registration 京械注准20242400773

Access comprehensive regulatory information for Cardiac troponin I detection kit (fluorescence immunoassay chromatography 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 京械注准20242400773 and owned by Beijing Strong Biotechnologies,Inc.. The device was approved on December 23, 2024.

This page provides complete registration details including registrant information, province location (Beijing), 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
京械注准20242400773
Cardiac troponin I detection kit (fluorescence immunoassay chromatography method)
心肌肌钙蛋白I测定试剂盒(荧光免疫层析法)
NMPA Registration Number: 京械注准20242400773
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Pricing
Intended Use
English

本试剂盒用于体外定量测定人血清、血浆或全血样本中的心肌肌钙蛋白I(cTnI)含量.

中文

本试剂盒用于体外定量测定人血清、血浆或全血样本中的心肌肌钙蛋白I(cTnI)含量。

Device Classification
Device Class
Class II
Model Specifications
10 servings/box; 25 servings/box; 50 servings/box; 100 servings/box.
10人份/盒;25人份/盒;50人份/盒;100人份/盒。
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20242400773
Approval Date
December 23, 2024
Expiry Date
December 22, 2029
Registrant
Name
Beijing Strong Biotechnologies,Inc.
北京九强生物技术股份有限公司
Province/Region
Beijing
北京
Address
5th floor, Kuanyi Building, No. 15 Huayuan East Road, Haidian District, Beijing
北京市海淀区花园东路15号旷怡大厦5层
Production Facility
Production Address
北京市怀柔区雁栖经济开发区雁栖北二街15号
Structure and Composition
English

注:校准曲线信息批特异.

中文

注:校准曲线信息批特异。

Storage Conditions and Expiration
English

2℃~30℃密封避光保存,有效期18个月.

中文

2℃~30℃密封避光保存,有效期18个月。

Additional Information
Changes
产品过期日期变更为:2℃~30℃密封避光保存,有效期18个月。。
Appendix
产品技术要求、说明书