China NMPA legacy archive 京械注准20242400773Cardiac 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)
Beijing Strong Biotechnologies,Inc.Class IINMPAApproved December 23, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class II
- Model specifications
- 10 servings/box; 25 servings/box; 50 servings/box; 100 servings/box.
- Approval department
- Beijing Municipal Drug Administration
10人份/盒；25人份/盒；50人份/盒；100人份/盒。
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
- Province/Region
- Beijing
- Address
- 5th floor, Kuanyi Building, No. 15 Huayuan East Road, Haidian District, Beijing
北京
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
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。
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
About this record
This static archive preserves historical registration fields and translations for Cardiac troponin I detection kit (fluorescence immunoassay chromatography method), registration 京械注准20242400773. It does not establish current authorization or complete current product details.
The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.