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N-acetyl-β-D-glucosaminidase assay reagent (MPT substrate method) - NMPA Registration 冀械注准20142400359

Access comprehensive regulatory information for N-acetyl-β-D-glucosaminidase assay reagent (MPT substrate 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20142400359 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20142400359
N-acetyl-β-D-glucosaminidase assay reagent (MPT substrate method)
N-乙酰-β-D-氨基葡萄糖苷酶测定试剂(MPT底物法)
NMPA Registration Number: 冀械注准20142400359
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Intended Use
English

For in vitro quantitative determination of N-acetyl-β-D-glucosasidase (NAG) viability in human serum or urine.

中文

用于体外定量测定人血清或尿液中N-乙酰-β-D-氨基葡萄糖苷酶(NAG)的活力。

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20142400359
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

Reagent 1: Citric acid buffer, 200 mmol/L. Reagent 2: 6-Methyl-2-mercaptopyridine-N-acetyl-β-D-glucosanoside (MPT-NAG), 19.3 mmol/L.

中文

试剂1:柠檬酸缓冲液,200mmol/L。试剂2:6-甲基-2-巯基吡啶-N-乙酰-β-D-氨基葡萄糖苷(MPT-NAG),19.3mmol/L。