Creatinine assay kit (creatine oxidase method) - NMPA Registration 鄂械注准20242405097

Access comprehensive regulatory information for Creatinine assay kit (creatine oxidase 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 鄂械注准20242405097 and owned by Wuhan Life Origin Biotech Joint Stock Co., Ltd.. The device was approved on July 25, 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.

Free Database

NMPA Official Data

Class II

鄂械注准20242405097

Creatinine assay kit (creatine oxidase method)

肌酐测定试剂盒（肌氨酸氧化酶法）

NMPA Registration Number: 鄂械注准20242405097

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Intended Use

English

This product is used for the quantitative determination of creatinine content in human serum, plasma and urine in vitro.

中文

本品用于体外定量测定人体血清、血浆、尿液中肌酐的含量。

Device Classification

Device Class

Class II

Model Specifications

Reagent 1: 60mL×3, Reagent 2: 60mL×1, Reagent 1: 24mL×1, Reagent 2: 8mL×1, Reagent 1: 90mL×2, Reagent 2: 60mL×1; Reagent 1: 50mL×3, Reagent 2: 50mL×1, Reagent 1: 60mL×1, Reagent 2: 20mL×1, Reagent 1: 60mL×2, Reagent 2: 20mL×2, Reagent 1: 40mL×3, Reagent 2: 40mL×1, Reagent 1: 60mL×6, Reagent 2: 60mL×2; Reagent 1: 60mL×9, Reagent 2: 60mL×3; Reagent 1: 6×64 test/box, Reagent 2: 6×64 test/box; Reagent 1: 12×64 test/box, Reagent 2: 12×64 test/box; Reagent 1:1×530 test/box, Reagent 2:1×530 test/box; Reagent 1:2×530 test/box, Reagent 2:2×530 test/box; Reagent 1: 3×530 test/box, Reagent 2: 3×530 test/box; Reagent 1: 6×530 test/box, Reagent 2: 6×530 test/box; Reagent 1:9×530 test/box, Reagent 2:9×530 test/box; Reagent 1:1×180 test/box, Reagent 2:1×180 test/box;

试剂1:60mL×3、试剂2:60mL×1；试剂1:24mL×1、试剂2:8mL×1；试剂1:90mL×2、试剂2:60mL×1；试剂1:50mL×3、试剂2:50mL×1；试剂1:60mL×1、试剂2:20mL×1；试剂1:60mL×2、试剂2:20mL×2；试剂1:40mL×3、试剂2:40mL×1；试剂1:60mL×6、试剂2:60mL×2；试剂1:60mL×9、试剂2:60mL×3；试剂1: 6×64测试/盒、试剂2:6×64测试/盒；试剂1: 12×64测试/盒、试剂2:12×64测试/盒；试剂1:1×530测试/盒、试剂2:1×530测试/盒；试剂1:2×530测试/盒、试剂2:2×530测试/盒；试剂1:3×530测试/盒、试剂2:3×530测试/盒；试剂1:6×530测试/盒、试剂2:6×530测试/盒；试剂1:9×530测试/盒、试剂2:9×530测试/盒；试剂1:1×180测试/盒、试剂2:1×180测试/盒；

Approval Department

Hubei Provincial Drug Administration

湖北省药品监督管理局

Registration Information

Registration Number

鄂械注准20242405097

Approval Date

July 25, 2024

Expiry Date

July 24, 2029

Registrant

Name

Wuhan Life Origin Biotech Joint Stock Co., Ltd.

武汉生之源生物科技股份有限公司

Province/Region

Hubei

湖北

Address

1st, 2nd and 3rd floor, No. 818 Gaoxin Avenue, Wuhan East Lake New Technology Development Zone, No. 818 High-tech Medical Equipment Park

武汉东湖新技术开发区高新大道818号高科医疗器械园B11号1楼、2楼、3楼

Production Facility

Production Address

武汉东湖新技术开发区高新大道818号高科医疗器械园B11号1楼、3楼

Structure and Composition

English

Reagent 1: 1,4-piperazine dieethanesulfonic acid; imidazolidinylurea; creatine amimidine hydrolase; sarcosine oxidase; ascorbate oxidase; Catalase; 4-Aminoantipyrine; Reagent 2: 1,4-piperazine dieethanesulfonic acid; Sodium azide; N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3-methylaniline sodium salt; Peroxidase; Creatinine aminolylase. (Please refer to the product manual for details)

中文

试剂1：1,4-哌嗪二乙磺酸；咪唑烷基脲；肌酸脒基水解酶；肌氨酸氧化酶；抗坏血酸氧化酶；过氧化氢酶；4-氨基安替比林；试剂2：1,4-哌嗪二乙磺酸；叠氮化钠；N-乙基-N-(2-羟基-3-磺丙基)-3-甲基苯胺钠盐；过氧化物酶；肌酐酰氨基水解酶。（具体内容详见产品说明书）

Storage Conditions and Expiration

English

This product can be sealed at 2°C~8°C and stored in the dark for 16 months.

中文

本品于2℃～8℃密封避光储存可稳定16个月。

Additional Information

Appendix

产品技术要求、说明书