心肌肌钙蛋白I/肌酸激酶同工酶/肌红蛋白联合检测试剂盒(干式免疫荧光发光法)
- Device class
- Class II
- Model specifications
- 卡型:1人份/袋、5人份/盒、10人份/盒、20人份/盒、25人份/盒、40人份/盒、50人份/盒、100人份/盒.卡型：1人份/袋、5人份/盒、10人份/盒、20人份/盒、25人份/盒、40人份/盒、50人份/盒、100人份/盒。
- Approval department
- Shandong Provincial Drug Administration山东省药品监督管理局
- Registration number
- 鲁械注准20242401060
- Approval date
- January 03, 2025
- Expiry date
- December 01, 2029
- Name
- Qingdao Hightop Biotech Co., Ltd.青岛汉唐生物科技有限公司
- Province/Region
- Shandong山东
- Address
- No. 369, Hedong Road, Qingdao High-tech Industrial Development Zone青岛高新技术产业开发区河东路369号
- Production address
- 青岛高新技术产业开发区河东路369号、潍坊经济开发区古亭街8877号（委托生产）
本试剂盒用于体外定量测定人血清、血浆或全血中心肌肌钙蛋白I(CTNI)/肌酸激酶同工酶(CK-MB)/肌红蛋白(Myo)的含量.
本试剂盒用于体外定量测定人血清、血浆或全血中心肌肌钙蛋白I（CTNI）/肌酸激酶同工酶（CK-MB）/肌红蛋白（Myo）的含量。
2 °C ~ 30 °C storage, valid for 24 months.
2℃~30℃保存，有效期24个月。
- Changes
- 生产地址由“青岛高新技术产业开发区河东路369号”变更为“青岛高新技术产业开发区河东路369号、潍坊经济开发区古亭街8877号（委托生产）”
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for 心肌肌钙蛋白I/肌酸激酶同工酶/肌红蛋白联合检测试剂盒(干式免疫荧光发光法) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 鲁械注准20242401060 and owned by Qingdao Hightop Biotech Co., Ltd.. The device was approved on January 03, 2025.
This page provides complete registration details including registrant information, province location (Shandong), 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.