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Amine oxidase assay kit (colorimetric method) - NMPA Registration 冀械注准20142400363

Access comprehensive regulatory information for Amine oxidase assay kit (colorimetric 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 冀械注准20142400363 and owned by Langfang Hengyi Biotechnology Co., Ltd.. The device was approved on November 07, 2019.

This page provides complete registration details including registrant information, province location (Hebei), 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
冀械注准20142400363
Amine oxidase assay kit (colorimetric method)
单胺氧化酶测定试剂盒(比色法)
NMPA Registration Number: 冀械注准20142400363
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Intended Use
English

For in vitro quantitative determination of monoamine oxidase activity in serum.

中文

用于体外定量测定血清中单胺氧化酶的活性。

Device Classification
Device Class
Class II
Approval Department
Hebei Food and Drug Administration
河北省食品药品监督管理局
Registration Information
Registration Number
冀械注准20142400363
Approval Date
November 07, 2019
Expiry Date
November 06, 2024
Registrant
Name
Langfang Hengyi Biotechnology Co., Ltd.
廊坊恒益生物技术有限公司
Province/Region
Hebei
河北
Address
No. 1, Yilan Road, Yongqing Taiwan New Industrial City, Langfang City, Hebei Province
河北省廊坊市永清台湾工业新城宜兰道1号
Production Facility
Production Address
河北省廊坊市永清台湾工业新城宜兰道1号
Structure and Composition
English

Trihydroxyaminomethane-hydrochloride (Tris-HCl) buffer, 100 mmol/L; α-Ketoglutaric acid, 14mmol/L; Disodium edta? 2Na),3mmol/L; Glutamate dehydrogenase (GLDH), 3KU/L; β-nicotinamide adenine dinucleoside disodium (NADH), 0.25mmol/L; adenosine diphosphate (ADP), 5mmol/L; Benzylamine, 10 mmol/L.

中文

三羟基氨基甲烷-盐酸(Tris-HCl)缓冲液,100mmol/L;α-酮戊二酸,14mmol/L; 乙二胺四乙酸二钠(EDTA?2Na),3mmol/L;谷氨酸脱氢酶(GLDH),3KU/L;β-烟酰胺腺嘌呤二核苷二钠(NADH),0.25mmol/L;二磷酸腺苷(ADP),5mmol/L; 苄胺,10mmol/L。