Homocysteine Assay Kit (Enzyme Cycling Method) - NMPA Registration 吉械注准20242400362

Access comprehensive regulatory information for Homocysteine Assay Kit (Enzyme Cycling 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20242400362 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.

Free Database

NMPA Official Data

Class II

吉械注准20242400362

Homocysteine Assay Kit (Enzyme Cycling Method)

同型半胱氨酸测定试剂盒(酶循环法)

NMPA Registration Number: 吉械注准20242400362

DJ Fang

MedTech Regulatory Expert

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Pricing

Intended Use

English

It is used for the quantitative determination of homocysteine content in human serum and plasma in vitro.

中文

用于体外定量测定人血清、血浆中同型半胱氨酸的含量。

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20242400362

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

Structure and Composition

English

试剂1(R1):丝氨酸 0.060g/L;还原型辅酶Ⅰ 0.30g/L. 试剂2(R2):乳酸脱氢酶 60KU/L;胱硫醚β-合成酶 0.017g/L;胱硫醚β-分解酶0.0005g/L;牛血清白蛋白 10g/L. 校准品(可选配):DL-高半胱氨酸,具体浓度详见标签. 质控品(可选配):DL-高半胱氨酸,具体浓度详见标签.

中文

试剂1（R1）：丝氨酸 0.060g/L；还原型辅酶Ⅰ 0.30g/L。试剂2（R2）：乳酸脱氢酶 60KU/L；胱硫醚β-合成酶 0.017g/L；胱硫醚β-分解酶0.0005g/L；牛血清白蛋白 10g/L。校准品(可选配)：DL-高半胱氨酸，具体浓度详见标签。质控品(可选配)：DL-高半胱氨酸，具体浓度详见标签。

Additional Information

Appendix

产品技术要求