肌酸激酶MB型同工酶(CK-MB)质控品
- Device class
- Class II
- Model specifications
- 水平1:1×1.0 mL、5×1.0 mL、9×1.0 mL;水平2:1×1.0 mL、5×1.0 mL、9×1.0 mL.水平1：1×1.0 mL、5×1.0 mL、9×1.0 mL；水平2：1×1.0 mL、5×1.0 mL、9×1.0 mL。
- Approval department
- Hubei Provincial Drug Administration湖北省药品监督管理局
- Registration number
- 鄂械注准20242405183
- Approval date
- September 14, 2024
- Expiry date
- September 13, 2029
- Name
- Wuhan Changli BIOTECH Co., Ltd.武汉市长立生物技术有限责任公司
- Province/Region
- Hubei湖北
- Address
- Room 01, 3rd floor, 4th floor, No. 388, Gaoxin 2nd Road, Wuhan Optics Valley International Biomedical Enterprise Accelerator, Phase 1.1, Phase 10, East Lake New Technology Development Zone, Wuhan武汉市东湖新技术开发区高新二路388号武汉光谷国际生物医药企业加速器1.1期10栋3层01室、4层01室
- Production address
- 武汉市东湖新技术开发区高新二路388号武汉光谷国际生物医药企业加速器1.1期10栋一、三、四层
与本公司生产的试剂盒配套使用,用于肌酸激酶MB型同工酶(CK-MB)项目的质量控制.
与本公司生产的试剂盒配套使用，用于肌酸激酶MB型同工酶（CK-MB）项目的质量控制。
水平1:Tris缓冲液,Proclin300,甘氨酸,肌酸激酶MB型同工酶.水平2:Tris缓冲液,Proclin300,甘氨酸,肌酸激酶MB型同工酶.(本产品为2个浓度水平的冻干粉末)(具体内容详见说明书)
水平1：Tris缓冲液，Proclin300，甘氨酸，肌酸激酶MB型同工酶。水平2：Tris缓冲液，Proclin300，甘氨酸，肌酸激酶MB型同工酶。（本产品为2个浓度水平的冻干粉末）（具体内容详见说明书）
2°C~8°C, valid for 12 months.
2℃～8℃，有效期12个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for 肌酸激酶MB型同工酶(CK-MB)质控品 in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 鄂械注准20242405183 and owned by Wuhan Changli BIOTECH Co., Ltd.. The device was approved on September 14, 2024.
This page provides complete registration details including registrant information, province location (Hubei), 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.