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γ-Glutamyltransferase Assay Kit (GCANA Substrate Method) - NMPA Registration 鲁械注准20152400621

Access comprehensive regulatory information for γ-Glutamyltransferase Assay Kit (GCANA 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 鲁械注准20152400621 and owned by Weifang Kanghua Biotechnology Co., Ltd. The device was approved on October 27, 2020.

This page provides complete registration details including registrant information, province location (Shandong), 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
鲁械注准20152400621
γ-Glutamyltransferase Assay Kit (GCANA Substrate Method)
γ-谷氨酰基转移酶测定试剂盒(GCANA底物法)
NMPA Registration Number: 鲁械注准20152400621
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Intended Use
English

For in vitro quantitative determination of γ-glutamyl transferase activity in human serum or plasma.

中文

用于体外定量测定人血清或血浆中γ-谷氨酰基转移酶的活性。

Device Classification
Device Class
Class II
Model Specifications
R1:60mL×4 R2:20mL×3;R1:80mL×1 R2:20mL×1; R1:60mL×4 R2:30mL×2;R1:80mL×2 R2:20mL×2; R1:40mL×2 R2:20mL×1;R1:50mL×4 R2:50mL×1;R1:20mL×4 R2:20mL×1;R1:40mL×2 R2:10mL×2;R1:20mL×4 R2:10mL×2.
R1:60mL×4 R2:20mL×3;R1:80mL×1 R2:20mL×1; R1:60mL×4 R2:30mL×2;R1:80mL×2 R2:20mL×2; R1:40mL×2 R2:20mL×1;R1:50mL×4 R2:50mL×1;R1:20mL×4 R2:20mL×1;R1:40mL×2 R2:10mL×2;R1:20mL×4 R2:10mL×2。
Approval Department
Shandong Provincial Drug Administration
山东省药品监督管理局
Registration Information
Registration Number
鲁械注准20152400621
Approval Date
October 27, 2020
Expiry Date
October 26, 2025
Registrant
Name
Weifang Kanghua Biotechnology Co., Ltd
潍坊市康华生物技术有限公司
Province/Region
Shandong
山东
Address
No. 699, Yuehe Road, Weifang Economic Development Zone
潍坊经济开发区月河路699号
Production Facility
Production Address
潍坊市经济开发区月河路699号
Structure and Composition
English

Reagent R1: Trimethylolaminomethane buffer 100mmol/L, Diglycopeptide 100mmol/L Reagent R2: L-γ-glutamyl-3-carboxy-4-nitroaniline 6mmol/L

中文

试剂R1:三羟甲基氨基甲烷缓冲液 100mmol/L、 双甘肽 100mmol/L试剂R2:L-γ-谷氨酰-3-羧基-4-硝基苯胺 6mmol/L

Storage Conditions and Expiration
English

Store at 2~8°C, valid for 12 months. After the reagent is opened, it can be refrigerated at 2~8 °C and stored for 20 days under dark conditions. Date of manufacture, expiration date: see label.

中文

2~8℃保存,有效期12个月。试剂开封后,在2~8℃冷藏,避光条件下可存放20天。生产日期、有效期至:见标签。