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氨测定试剂盒(谷氨酸脱氢酶法) - NMPA Registration 京械注准20242400684

Access comprehensive regulatory information for 氨测定试剂盒(谷氨酸脱氢酶法) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20242400684 and owned by Beijing Strong Biotechnologies,Inc.. The device was approved on November 12, 2024.

This page provides complete registration details including registrant information, province location (Beijing), 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
京械注准20242400684
氨测定试剂盒(谷氨酸脱氢酶法)
氨测定试剂盒（谷氨酸脱氢酶法)
NMPA Registration Number: 京械注准20242400684
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Intended Use
English

This kit is used for the in vitro quantitative determination of ammonia (AMM) content in human plasma.

中文

本试剂盒用于体外定量测定人血浆中氨（AMM）的含量。

Device Classification
Device Class
Class II
Model Specifications
试剂1:2;54mL、试剂2:2;22mL;试剂1:2;52mL、试剂2:2;21mL;840测试/盒;810测试/盒;校准品(单水平):1;1mL;质控品(水平1):1;1mL;质控品(水平2):1;1mL.
试剂1:2;54mL、试剂2:2;22mL；试剂1:2;52mL、试剂2:2;21mL；840测试/盒；810测试/盒；校准品（单水平）：1;1mL；质控品（水平1）：1;1mL；质控品（水平2）：1;1mL。
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20242400684
Approval Date
November 12, 2024
Expiry Date
November 11, 2029
Registrant
Name
Beijing Strong Biotechnologies,Inc.
北京九强生物技术股份有限公司
Province/Region
Beijing
北京
Address
5th floor, Kuanyi Building, No. 15 Huayuan East Road, Haidian District, Beijing
北京市海淀区花园东路15号旷怡大厦5层
Production Facility
Production Address
北京市怀柔区雁栖经济开发区雁栖北二街15号
Structure and Composition
English

试剂成分浓度试剂1:还原型烟酰胺腺嘌呤二核苷酸磷酸alpha;-酮戊二酸0.28mmol/L10mmol/L试剂2:谷氨酸脱氢酶13KU/L校准品(液体,单水平):Goodrsquo;s缓冲液氯化铵100mmol/L单水平:200-400mu;mol/L质控品(液体,2水平):Goodrsquo;s缓冲液氯化铵100mmol/L水平1:50-250mu;mol/L水平2:280-500mu;mol/L

中文

试剂成分浓度试剂1：还原型烟酰胺腺嘌呤二核苷酸磷酸alpha;-酮戊二酸0.28mmol/L10mmol/L试剂2：谷氨酸脱氢酶13KU/L校准品（液体，单水平）：Goodrsquo;s缓冲液氯化铵100mmol/L单水平：200-400mu;mol/L质控品（液体，2水平）：Goodrsquo;s缓冲液氯化铵100mmol/L水平1：50-250mu;mol/L水平2：280-500mu;mol/L

Storage Conditions and Expiration
English

试剂盒在2℃~ 8℃密封避光保存,有效期12个月.

中文

试剂盒在2℃~ 8℃密封避光保存，有效期12个月。