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亮氨酸氨基肽酶测定试剂盒(L-亮氨酰对硝基苯胺底物法) - NMPA Registration 沪械注准20242400042

Access comprehensive regulatory information for 亮氨酸氨基肽酶测定试剂盒(L-亮氨酰对硝基苯胺底物法) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 沪械注准20242400042 and owned by Shanghai Kehua Bio-Engineering Co., Ltd.. The device was approved on February 04, 2024.

This page provides complete registration details including registrant information, province location (Shanghai), 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
沪械注准20242400042
亮氨酸氨基肽酶测定试剂盒(L-亮氨酰对硝基苯胺底物法)
NMPA Registration Number: 沪械注准20242400042
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Intended Use
English

本试剂盒供医疗机构用于体外定量测定人血清、血浆或尿液样本中亮氨酸氨基肽酶(LAP)的活性.作辅助诊断用.

中文

本试剂盒供医疗机构用于体外定量测定人血清、血浆或尿液样本中亮氨酸氨基肽酶(LAP)的活性。作辅助诊断用。

Device Classification
Device Class
Class II
Model Specifications
See annex.
见附件.
Approval Department
Shanghai Municipal Drug Administration
上海市药品监督管理局
Registration Information
Registration Number
沪械注准20242400042
Approval Date
February 04, 2024
Expiry Date
February 03, 2029
Registrant
Name
Shanghai Kehua Bio-Engineering Co., Ltd.
上海科华生物工程股份有限公司
Province/Region
Shanghai
上海
Address
1189 Qinzhou North Road, Xuhui District, Shanghai
上海市徐汇区钦州北路1189号
Production Facility
Production Address
上海市徐汇区钦州北路1189号
Structure and Composition
English

试剂1(R1):Tris缓冲液;试剂2(R2):柠檬酸盐缓冲液、L-亮氨酰对硝基苯胺;校准品:人血基质、 亮氨酸氨基肽酶;质控品L:人血基质、 亮氨酸氨基肽酶;质控品H:人血基质、亮氨酸氨基肽酶.

中文

试剂1(R1):Tris缓冲液;试剂2(R2):柠檬酸盐缓冲液、L-亮氨酰对硝基苯胺;校准品:人血基质、 亮氨酸氨基肽酶;质控品L:人血基质、 亮氨酸氨基肽酶;质控品H:人血基质、亮氨酸氨基肽酶。

Storage Conditions and Expiration
English

Store at 2~8°C away from light, and the expiration date is 9 months.

中文

2~8℃避光保存,有效期为9个月。

Additional Information
Changes
1、产品注册证变更包装规格、有效期,详见附件1(共3页)。 2、产品技术要求变更产品规格、装量指标,详见附件2(共3页)。 3、产品说明书变更包装规格、有效期、适用仪器及其他文字性变更,详见附件3(共5页)。;本文件与“沪械注准20242400042”注册证共同使用。;2024-12-20