Creatine kinase isoenzyme assay kit (latex immunoturbidimetry)
- Device class
- Class II
- Model specifications
- See attached leaflet for details详见附页
- Approval department
- Shanghai Municipal Drug Administration上海市药品监督管理局
- Registration number
- 沪械注准20242400425
- Approval date
- December 09, 2024
- Expiry date
- December 08, 2029
- Name
- Shanghai Fosun LONG March MEDICAL Science Co., Ltd.复星诊断科技（上海）有限公司
- Province/Region
- Shanghai上海
- Address
- 830 Chengyin Road, Baoshan District, Shanghai上海市宝山区城银路830号
- Production address
- 江苏省泰州市江苏省泰州市泰州医药高新区秀水路22号7-1幢
本试剂盒用于体外定量测定人血清或血浆中肌酸激酶同工酶(CK-MB)的含量.
本试剂盒用于体外定量测定人血清或血浆中肌酸激酶同工酶（CK-MB）的含量。
试剂1(R1):4-羟乙基哌嗪乙磺酸(HEPES)缓冲液,聚乙二醇,牛血清蛋白(BSA);试剂2(R2):包被抗肌酸激酶同工酶MB(CK-MB)抗体的胶乳颗粒,甘氨酸缓冲液;校准品:肌酸激酶同工酶抗原,磷酸缓冲液;质控品:肌酸激酶同工酶抗原,磷酸缓冲液.
试剂1（R1）:4-羟乙基哌嗪乙磺酸（HEPES）缓冲液，聚乙二醇，牛血清蛋白（BSA）；试剂2（R2）：包被抗肌酸激酶同工酶MB（CK-MB）抗体的胶乳颗粒，甘氨酸缓冲液；校准品：肌酸激酶同工酶抗原，磷酸缓冲液；质控品：肌酸激酶同工酶抗原，磷酸缓冲液。
1.在2～8℃避光、密封的储存条件下,试剂盒自生产之日起有效期为12个月. 2.试剂1和试剂2启用后,置于分析仪上可稳定28天. 3.校准品、质控品复溶后2℃～8℃密封避光保存可稳定3天.
1.在2～8℃避光、密封的储存条件下，试剂盒自生产之日起有效期为12个月。 2.试剂1和试剂2启用后，置于分析仪上可稳定28天。 3.校准品、质控品复溶后2℃～8℃密封避光保存可稳定3天。
Access comprehensive regulatory information for Creatine kinase isoenzyme assay kit (latex immunoturbidimetry) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 沪械注准20242400425 and owned by Shanghai Fosun LONG March MEDICAL Science Co., Ltd.. The device was approved on December 09, 2024.
This page provides complete registration details including registrant information, province location (Shanghai), 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.