China NMPA legacy archive 皖械注准20222400110Creatine Kinase Isoenzyme Determination Kit (Latex Turbidimetric Method)
- Device class
- Class II
- Approval department
- Anhui Provincial Drug Administration
- Registration number
- 皖械注准20222400110
- Approval date
- May 23, 2022
- Expiry date
- May 22, 2027
- Province/Region
- Anhui
- Address
- Anhui Province Hefei City Economic Development District Taohua Industrial Park prosperous Avenue Industrial Investment Liheng Industrial Plaza 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。
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