Creatine Kinase Isoenzyme Determination Kit (Latex Turbidimetric Method)
- Device class
- Class II
- Approval department
- Anhui Provincial Drug Administration安徽省药品监督管理局
- Registration number
- 皖械注准20222400110
- Approval date
- May 23, 2022
- Expiry date
- May 22, 2027
- Name
- Anhui Daqian Bio-Engineering Limited Company安徽大千生物工程有限公司
- Province/Region
- Anhui安徽
- Address
- Anhui Province Hefei City Economic Development District Taohua Industrial Park prosperous Avenue Industrial Investment Liheng Industrial Plaza B12C安徽省合肥市经开区桃花工业园繁华大道工投·立恒工业广场B12C
- Production address
- 安徽省合肥市经开区桃花工业园繁华大道工投·立恒工业广场B12C
For in vitro quantitative detection of creatine kinase isoenzyme (CK-MB) in human serum.
用于体外定量检测人血清中肌酸激酶同工酶(CK-MB)的含量。
Reagent 1 (R1): HEPES buffer 100mol/L Reagent 2 (R2): phosphate buffer 100mol/L, coated with anti-creatine kinase isoenzyme antibody latex granule 1.0%; Calibrators (optional): creatine kinase isoenzyme, phosphate buffer; Controls (optional): creatine kinase isoenzyme, phosphate buffer.
试剂1（R1）：HEPES缓冲液 100mol/L试剂2（R2）：磷酸盐缓冲液 100mol/L，包被抗肌酸激酶同工酶抗体胶乳颗粒 1.0%；校准品（选配）：肌酸激酶同工酶、磷酸盐缓冲液；质控品（选配）：肌酸激酶同工酶、磷酸盐缓冲液。
Storage at 2 °C ~ 8 °C in the dark can be stable for 18 months to prevent freezing. After opening, it can be stable for 30 days when stored at 2 °C ~ 8 °C.
2℃～8℃避光贮存可稳定18个月，防止冷冻。开瓶后于2℃～8℃贮存可稳定30天。
Access comprehensive regulatory information for Creatine Kinase Isoenzyme Determination Kit (Latex Turbidimetric 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 皖械注准20222400110 and owned by Anhui Daqian Bio-Engineering Limited Company. The device was approved on May 23, 2022.
This page provides complete registration details including registrant information, province location (Anhui), 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.