吉械注准20242400363

Cystatin C Detection Kit (Latex Immunoturbidimetric Method)

胱抑素C测定试剂盒(胶乳免疫比浊法)

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

Device classification

Device class: Class II
Model specifications: R1:1×20mL R2:1×5mL R1:1×30mL R2:1×8mL R1:1×40mL R2:1×10mL R1:1×60mL R2:1×15mL R1:1×80mL R2:1×20mL R1:2×30mL R2:1×15mL R1:2×35mL R2:1×20mL R1:2×40mL R2:1×20mL R1:2×40mL R2:2×10mL R1:2×48mL R2:2×12mL R1:2×60mL R2:1×30mL R1:2×60mL R2:1×35mL R1:2×60mL R2:2×15mL R1:2×80mL R2:1×40mL R1:2×80mL R2:2×20mL R1:2×120mL R2:1×60mL R1:4×20mL R2:4×5mL R1:4×30mL R2:2×15mL R1:4×35mL R2:2×20mL R1:4×40mL R2:2×20mL R1:4×50mL R2:2×25mL R1:4×50mL R2:3×20mL R1:4×60mL R2:2×30mL R1:4×60mL R2:2×35mL R1:4×60mL R2:4×15mL R1:6×62mL R2:6×19mL R1:6×66mL R2:6×16mL R1:4×100mL R2:2×50mL R1:4×120mL R2:2×60mL R1:4×653mL R2:4×146mL R1:4×653mL R2:4×283mL 2×100T(R1:2×15mL R2:2×5mL) 2×160T(R1:2×44mL R2:2×11mL) 2×300T(R1:2×72mL R2:2×18mL) 6×60T(R1:6×17.2mL R2:6×4.3mL) 12×60T(R1:12×17.2mL R2:12×4.3mL) 140T(R1:1×21mL R2:1×21mL) 200T(R1:1×27mL R2:1×8mL)300T(R1:1×33mL R2:1×9mL) 校准品(可选配):水平1:1mL 水平2:1mL 水平3:1mL 水平4:1mL 水平5:1mL质控品(可选配):水平1:1mL水平2:1mL
R1:1×20mL R2:1×5mL R1:1×30mL R2:1×8mL R1:1×40mL R2:1×10mL R1:1×60mL R2:1×15mL R1:1×80mL R2:1×20mL R1:2×30mL R2:1×15mL R1:2×35mL R2:1×20mL R1:2×40mL R2:1×20mL R1:2×40mL R2:2×10mL R1:2×48mL R2:2×12mL R1:2×60mL R2:1×30mL R1:2×60mL R2:1×35mL R1:2×60mL R2:2×15mL R1:2×80mL R2:1×40mL R1:2×80mL R2:2×20mL R1:2×120mL R2:1×60mL R1:4×20mL R2:4×5mL R1:4×30mL R2:2×15mL R1:4×35mL R2:2×20mL R1:4×40mL R2:2×20mL R1:4×50mL R2:2×25mL R1:4×50mL R2:3×20mL R1:4×60mL R2:2×30mL R1:4×60mL R2:2×35mL R1:4×60mL R2:4×15mL R1:6×62mL R2:6×19mL R1:6×66mL R2:6×16mL R1:4×100mL R2:2×50mL R1:4×120mL R2:2×60mL R1:4×653mL R2:4×146mL R1:4×653mL R2:4×283mL 2×100T（R1:2×15mL R2:2×5mL） 2×160T（R1:2×44mL R2:2×11mL） 2×300T（R1:2×72mL R2:2×18mL） 6×60T（R1:6×17.2mL R2:6×4.3mL） 12×60T（R1:12×17.2mL R2:12×4.3mL） 140T（R1:1×21mL R2:1×21mL） 200T（R1:1×27mL R2:1×8mL）300T（R1:1×33mL R2:1×9mL）校准品(可选配)：水平1:1mL 水平2:1mL 水平3:1mL 水平4:1mL 水平5:1mL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20242400363
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 cystatin C content in human serum, plasma and urine.

中文

用于体外定量测定人血清、血浆和尿液中胱抑素C的含量。

Structure and composition

English

试剂1(R1):三(羟甲基)氨基甲烷缓冲液 50mmol/L;氯化钠15g/L. 试剂2(R2):甘氨酸缓冲液 20mmol/L;兔抗人胱抑素C抗体 100mg/L;胶乳微球 30ml/L. 校准品(可选配):胱抑素C抗原,具体浓度详见标签. 质控品(可选配):胱抑素C抗原,具体浓度详见标签.

中文

试剂1（R1）：三（羟甲基）氨基甲烷缓冲液 50mmol/L；氯化钠15g/L。试剂2（R2）：甘氨酸缓冲液 20mmol/L；兔抗人胱抑素C抗体 100mg/L；胶乳微球 30ml/L。校准品(可选配)：胱抑素C抗原，具体浓度详见标签。质控品(可选配)：胱抑素C抗原，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 Cystatin C Detection Kit (Latex Immunoturbidimetric 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20242400363 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.