China NMPA legacy archive 苏械注准20232401317Creatine Kinase Isoenzyme Test Kit (Latex Immuno Turbidimetric Assay)
- Device class
- Class II
- Model specifications
- Reagent 1: 1×60mL Reagent 2: 1×20mL Reagent 1:2×60mL Reagent 2: 1×40mLReagent 1:3×60mL Reagent 2: 1×60mL Reagent 1:4×60mL Reagent 2: 2×40mLReagent 1:5×60mL Reagent 2: 2×50mL Reagent 1:6×60mL Reagent 2: 2×60mL Reagent 1:7×60mL Reagent 2: 2×70mL Reagent 1:8×60mL Reagent 2: 4×40mL Reagent 1:1×90mL Reagent 2: 1×30mL Reagent 1:2×90mL Reagent 2: 1×60mLReagent 1:3×90mL Reagent 2: 1×90mL Reagent 1:4×90mL Reagent 2: 2×60mL Reagent 1:5×90mL Reagent 2: 2×75mL Reagent 1:6×90mL Reagent 2: 2×90mL Reagent 1:1×45mL Reagent 2: 1×15mL Reagent 1:2×45mL Reagent 2: 1×30mL Reagent 1:3×45mL Reagent 2: 1×45mL Reagent 1:4×45mL Reagent 2: 1×60mLReagent 1:4×45mL Reagent 2: 2×30mL Reagent 1:6×45mL Reagent 2: 2×45mL Reagent 1:8×45mL Reagent 2: 3×40mL Reagent 1:8×45mL Reagent 2: 2×60mLReagent 1:1×24mL Reagent 2: 1×8mL Reagent 1:1×18mL Reagent 2: 1×6mL Reagent 1:1×3L Reagent 2:1×1L Reagent 1: 2×45ml Reagent 2: 2×15ml Reagent 1: 2×60ml Reagent 2: 2×20ml Reagent 1: 3×60ml Reagent 2: 3×20ml Reagent 1: 4×60ml Reagent 2: 4×20ml Reagent 1: 5×60ml Reagent 2: 5×20ml Reagent 1: 6×60ml Reagent 2: 6×20ml Reagent 1: 7×60ml Reagent 2: 7×20ml Reagent 1: 8×60ml Reagent 2: 820ml Reagent 2: 8×20ml
- Approval department
- Jiangsu Provincial Drug Administration
- Registration number
- 苏械注准20232401317
- Approval date
- September 15, 2023
- Expiry date
- September 14, 2028
- Province/Region
- Jiangsu
- Address
- The third floor of the south building of Gaochuang Park, Shuyang County, Suqian City
- Production address
- 宿迁市沭阳县高创园南楼三层
For in vitro quantitative detection of creatine kinase isoenzyme (CKMB) activity in human serum or plasma.
用于体外定量检测人血清或血浆中肌酸激酶同工酶（CKMB）的活性。
Reagent 1: 4-Hydroxyethylpiperazine ethanesulfonic acid (HEPES) buffer (pH=7.5), 50mmol/L; bovine serum albumin (BSA), 6g/L; polyethylene glycol 6000 (PEG-6000), 40g/L; ProClin300, 0.03%. Reagent 2: Glycine buffer (pH=9.0), 50mmol/L, rabbit anti-human creatine kinase isoenzyme MB antibody latex granule, 0.1% (v/w), Tween 20 (Tween20), 0.1%; ProClin300,0.03%.
试剂1：4-羟乙基哌嗪乙磺酸（HEPES）缓冲液(pH=7.5)，50mmol/L；牛血清白蛋白（BSA），6g/L；聚乙二醇6000（PEG-6000），40g/L；ProClin300，0.03%。 试剂2： 甘氨酸缓冲液(pH=9.0)，50mmol/L；兔抗人肌酸激酶同工酶MB抗体胶乳颗粒，0.1%（v/w)；吐温20（Tween20），0.1%；ProClin300，0.03%。
1.2 °C ~ 8 °C sealed storage, valid for 12 months. 2. After opening, 2 °C ~ 8 °C sealed storage, can be stable for 28 days.
1.2℃～8℃密封储存，有效期12个月。2.开瓶后2℃～8℃密封储存，可稳定28天。
- Appendix
- 产品技术要求、说明书
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