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Homocysteine Detection Kit (Cyclic Enzyme Rate Method) - NMPA Registration 湘械注准20222400075

Access comprehensive regulatory information for Homocysteine Detection Kit (Cyclic Enzyme Rate 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 湘械注准20222400075 and owned by Hunan Huaxi Pharmaceutical Co., Ltd.. The device was approved on January 18, 2022.

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

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Class II
湘械注准20222400075
Homocysteine Detection Kit (Cyclic Enzyme Rate Method)
同型半胱氨酸测定试剂盒(循环酶速率法)
NMPA Registration Number: 湘械注准20222400075
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Intended Use
English

It is used by medical institutions to quantitatively measure the content of homocysteine in serum for auxiliary diagnosis.

中文

供医疗机构用于定量测定血清中的同型半胱氨酸含量,作辅助诊断用。

Device Classification
Device Class
Class II
Model Specifications
R1:1×37ml,R2:1×10ml; R1:1×74ml,R2:1×20ml; R1:2×37ml,R2:2×10ml; R1:2×74ml,R2:2×20ml; R1:4×37ml,R2:4×10ml; R1:4×74ml,R2:4×20ml; R1:6×37ml,R2:6×10ml; R1:6×74ml,R2: 6×20ml; R1:1×3700ml,R2:1×1000ml.
R1:1×37ml,R2:1×10ml;R1:1×74ml,R2:1×20ml;R1:2×37ml,R2:2×10ml;R1:2×74ml,R2:2×20ml;R1:4×37ml,R2:4×10ml;R1:4×74ml,R2:4×20ml;R1:6×37ml,R2:6×10ml;R1:6×74ml,R2: 6×20ml;R1:1×3700ml,R2:1×1000ml。
Approval Department
Hunan Provincial Drug Administration
湖南省药品监督管理局
Registration Information
Registration Number
湘械注准20222400075
Approval Date
January 18, 2022
Expiry Date
January 17, 2027
Registrant
Name
Hunan Huaxi Pharmaceutical Co., Ltd.
湖南华曦医药有限公司
Province/Region
Hunan
湖南
Address
No. 18 Xiangtai Road, Liuyang Economic and Technological Development Zone, Changsha E Center Phase I, Building A1, 2nd Floor, 2nd Floor Plant 201, 202
浏阳经济技术开发区湘台路18号长沙E中心一期A1栋2层201、202号厂房
Production Facility
Production Address
浏阳经济技术开发区湘台路18号长沙E中心一期A1栋2层201、202号厂房
Structure and Composition
English

Reagent 1: S-adenosylmethionine (SAM), β-nicotinamide adenine dinucleotide reduced (NADH), tris(2carboxyethyl) phosphophosphine chloride (TCEP), α-ketoglutaric acid; Reagent 2: Hcy methyltransferase (HMTase), glutamate dehydrogenase (GLDH), S-adenosylhomocysteine (SAH) hydrolase, adenosine deaminase (ADA).

中文

试剂1:S-腺苷甲硫氨酸(SAM)、β-烟酰胺腺嘌呤二核苷酸还原型 (NADH)、三(2羧乙基)磷氯化氢(TCEP)、α-酮戊二酸;试剂2: Hcy甲基转移酶(HMTase)、谷氨酸脱氢酶(GLDH)、S-腺苷同型半胱氨酸(SAH)水解酶、腺苷脱氨酶(ADA)。

Storage Conditions and Expiration
English

Store at 2~8 °C in the dark for one year.

中文

2~8℃避光保存一年。

Additional Information
Changes
变更时间:2022-03-25变更内容:1、变更申请人住所由“湖南省长沙市雨花区振华路519号聚合工业园14栋602房”变更为“浏阳经济技术开发区湘台路18号长沙E中心一期A1栋2层201、202号厂房”。2、变更生产地址由“湖南省长沙市雨花区振华路519号聚合工业园14栋602房”变更为“浏阳经济技术开发区湘台路18号长沙E中心一期A1栋2层201、202号厂房”。