吉械注准20242400361

Ischemia-modified Albumin Determination Kit (Albumin-Cobalt Binding Method)

缺血修饰白蛋白测定试剂盒(白蛋白-钴结合法)

Jilin Base Egg Biological Technology Co., Ltd.·Class II·NMPA·Approved July 16, 2024

Device classification

Device class: Class II
Model specifications: R1:1×15mL R2:1×5mL R1:1×30mL R2:1×10mL R1:1×30mL R2:1×12mL R1:1×33mL R2:1×13mL R1:1×45mL R2:1×15mL R1:1×60mL R2:1×20mL R1:2×15mL R2:1×10mL R1:2×30mL R2:1×20mL R1:2×30mL R2:2×10mL R1:2×45mL R2:2×15mL R1:2×45mL R2:2×20mL R1:2×55mL R2:2×20mL R1:2×60mL R2:1×40mL R1:2×60mL R2:1×45mL R1:2×60mL R2:2×20mL R1:2×90mL R2:1×60mL R1:2×90mL R2:2×30mL R1:2×120mL R2:2×40mL R1:3×40mL R2:3×15mL R1:3×45mL R2:3×15mL R1:3×60mL R2:1×60mL R1:3×60mL R2:3×20mL R1:4×30mL R2:2×20mL R1:4×45mL R2:2×30mL R1:4×45mL R2:4×15mL R1:4×55mL R2:4×20mL R1:4×60mL R2:2×40mL R1:4×60mL R2:2×45mL R1:4×60mL R2:4×20mL R1:4×90mL R2:2×60mL R1:4×651mL R2:4×230mL R1:6×13.5mL R2:6×4.3mL R1:6×54mL R2:6×20mL R1:6×250mL R2:6×97mL R1:8×60mL R2:8×20mL R1:12×4.2mL R2:6×2.9mL R1:24×3.8mL R2:12×2.6mL 150T(R1:1×20mL R2:1×6mL) 2×100T(R1:2×15mL R2:2×5mL) 2×260T(R1:2×70mL R2:2×21mL) 6×52T(R1:6×16.8mL R2:6×5.8mL) 12×52T(R1:12×16.8mL R2:12×5.8mL)校准品(可选配):水平1:1mL 水平2:1mL 质控品(可选配):水平1:1mL 水平2:1mL
R1:1×15mL R2:1×5mL R1:1×30mL R2:1×10mL R1:1×30mL R2:1×12mL R1:1×33mL R2:1×13mL R1:1×45mL R2:1×15mL R1:1×60mL R2:1×20mL R1:2×15mL R2:1×10mL R1:2×30mL R2:1×20mL R1:2×30mL R2:2×10mL R1:2×45mL R2:2×15mL R1:2×45mL R2:2×20mL R1:2×55mL R2:2×20mL R1:2×60mL R2:1×40mL R1:2×60mL R2:1×45mL R1:2×60mL R2:2×20mL R1:2×90mL R2:1×60mL R1:2×90mL R2:2×30mL R1:2×120mL R2:2×40mL R1:3×40mL R2:3×15mL R1:3×45mL R2:3×15mL R1:3×60mL R2:1×60mL R1:3×60mL R2:3×20mL R1:4×30mL R2:2×20mL R1:4×45mL R2:2×30mL R1:4×45mL R2:4×15mL R1:4×55mL R2:4×20mL R1:4×60mL R2:2×40mL R1:4×60mL R2:2×45mL R1:4×60mL R2:4×20mL R1:4×90mL R2:2×60mL R1:4×651mL R2:4×230mL R1:6×13.5mL R2:6×4.3mL R1:6×54mL R2:6×20mL R1:6×250mL R2:6×97mL R1:8×60mL R2:8×20mL R1:12×4.2mL R2:6×2.9mL R1:24×3.8mL R2:12×2.6mL 150T（R1:1×20mL R2:1×6mL） 2×100T（R1:2×15mL R2:2×5mL） 2×260T（R1:2×70mL R2:2×21mL） 6×52T（R1:6×16.8mL R2:6×5.8mL） 12×52T（R1:12×16.8mL R2:12×5.8mL）校准品(可选配)：水平1:1mL 水平2:1mL 质控品(可选配)：水平1:1mL 水平2:1mL
Approval department: Jilin Provincial Drug Administration
吉林省药品监督管理局

Registration information

Registration number: 吉械注准20242400361
Approval date: July 16, 2024
Expiry date: July 15, 2029

Registrant

Name: Jilin Base Egg Biological Technology Co., Ltd.
吉林基蛋生物科技有限公司
Province/Region: Jilin
吉林
Address: No. 1399, Ya'an Road, Beihu Science and Technology Development Zone, Changchun City, Jilin Province
吉林省长春市北湖科技开发区雅安路1399号

Production facility

Production address: 吉林省长春市北湖科技开发区雅安路1399号

Intended use

English

It is used for in vitro quantitative determination of ischemic modified albumin content in human serum and plasma.

中文

用于体外定量测定人血清、血浆中缺血修饰白蛋白的含量。

Structure and composition

English

Reagent 1 (R1): Cobalt chloride 10mmol/L. Reagent 2 (R2): dithiothreitol 200mmol/L. Calibrator (optional): Bovine serum albumin, see label for specific concentrations. Control (optional): Bovine serum albumin, see label for specific concentrations.

中文

试剂1（R1）：氯化钴 10mmol/L。试剂2（R2）：二硫苏糖醇 200mmol/L。校准品(可选配)：牛血清白蛋白，具体浓度详见标签。质控品(可选配)：牛血清白蛋白，具体浓度详见标签。

Additional information

Appendix: 产品技术要求

About this record

Access comprehensive regulatory information for Ischemia-modified Albumin Determination Kit (Albumin-Cobalt Binding 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 吉械注准20242400361 and owned by Jilin Base Egg Biological Technology Co., Ltd.. The device was approved on July 16, 2024.

This page provides complete registration details including registrant information, province location (Jilin), 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.