Creatine 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试剂1：1×60mL 试剂2：1×20mL试剂1：2×60mL 试剂2：1×40mL试剂1：3×60mL 试剂2：1×60mL试剂1：4×60mL 试剂2：2×40mL试剂1：5×60mL 试剂2：2×50mL试剂1：6×60mL 试剂2：2×60mL试剂1：7×60mL 试剂2：2×70mL试剂1：8×60mL 试剂2：4×40mL试剂1：1×90mL 试剂2：1×30mL试剂1：2×90mL 试剂2：1×60mL试剂1：3×90mL 试剂2：1×90mL试剂1：4×90mL 试剂2：2×60mL试剂1：5×90mL 试剂2：2×75mL试剂1：6×90mL 试剂2：2×90mL试剂1：1×45mL 试剂2：1×15mL试剂1：2×45mL 试剂2：1×30mL试剂1：3×45mL 试剂2：1×45mL试剂1：4×45mL 试剂2：1×60mL试剂1：4×45mL 试剂2：2×30mL试剂1：6×45mL 试剂2：2×45mL试剂1：8×45mL 试剂2：3×40mL试剂1：8×45mL 试剂2：2×60mL试剂1：1×24mL 试剂2：1×8mL试剂1：1×18mL 试剂2：1×6mL试剂1：1×3L 试剂2：1×1L试剂1：2×45ml 试剂2：2×15ml试剂1：2×60ml 试剂2：2×20ml试剂1：3×60ml 试剂2：3×20ml试剂1：4×60ml 试剂2：4×20ml试剂1：5×60ml 试剂2：5×20ml试剂1：6×60ml 试剂2：6×20ml试剂1：7×60ml 试剂2：7×20ml试剂1：8×60ml 试剂2：8×20ml
- Approval department
- Jiangsu Provincial Drug Administration江苏省药品监督管理局
- Registration number
- 苏械注准20232401317
- Approval date
- September 15, 2023
- Expiry date
- September 14, 2028
- Name
- Jiangsu MDK BIOTECH Co., Ltd.江苏麦得科生物科技有限公司
- Province/Region
- Jiangsu江苏
- Address
- The third floor of the south building of Gaochuang Park, Shuyang County, Suqian City宿迁市沭阳县高创园南楼三层
- 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
Access comprehensive regulatory information for Creatine Kinase Isoenzyme Test Kit (Latex Immuno Turbidimetric Assay) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 苏械注准20232401317 and owned by Jiangsu MDK BIOTECH Co., Ltd.. The device was approved on September 15, 2023.
This page provides complete registration details including registrant information, province location (Jiangsu), 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.