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Matrix Metalloproteinase-3 Determination Kit (Latex Enhanced Immunoturbidimetric Method) - NMPA Registration 皖械注准20222400109

Access comprehensive regulatory information for Matrix Metalloproteinase-3 Determination Kit (Latex Enhanced Immunoturbidimetric 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 皖械注准20222400109 and owned by Anhui Daqian Bio-Engineering Limited Company. The device was approved on May 23, 2022.

This page provides complete registration details including registrant information, province location (Anhui), 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
皖械注准20222400109
Matrix Metalloproteinase-3 Determination Kit (Latex Enhanced Immunoturbidimetric Method)
基质金属蛋白酶-3测定试剂盒(胶乳增强免疫比浊法)
NMPA Registration Number: 皖械注准20222400109
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Intended Use
English

For in vitro quantitative detection of matrix metalloproteinase-3 (MMP-3) content in human serum.

中文

用于体外定量检测人血清中基质金属蛋白酶-3(MMP-3)的含量。

Device Classification
Device Class
Class II
Approval Department
Anhui Provincial Drug Administration
安徽省药品监督管理局
Registration Information
Registration Number
皖械注准20222400109
Approval Date
May 23, 2022
Expiry Date
May 22, 2027
Registrant
Name
Anhui Daqian Bio-Engineering Limited Company
安徽大千生物工程有限公司
Province/Region
Anhui
安徽
Address
Anhui Province Hefei City Economic Development District Taohua Industrial Park prosperous Avenue Industrial Investment Liheng Industrial Plaza B12C
安徽省合肥市经开区桃花工业园繁华大道工投·立恒工业广场B12C
Production Facility
Production Address
安徽省合肥市经开区桃花工业园繁华大道工投·立恒工业广场B12C
Structure and Composition
English

Reagent 1 (R1): phosphate buffer 110 mmol/L; Reagent 2 (R2): phosphate buffer 110 mmol/L; Anti-human MMP-3 antibody latex granules 1.4%; Calibrators (optional): matrix metalloproteinase-3, phosphate buffer; Controls (optional): matrix metalloproteinase-3, phosphate buffer.

中文

试剂1(R1):磷酸盐缓冲液 110 mmol/L;试剂2(R2):磷酸盐缓冲液 110 mmol/L;抗人MMP-3抗体胶乳颗粒 1.4%;校准品(选配):基质金属蛋白酶-3、磷酸盐缓冲液;质控品(选配):基质金属蛋白酶-3、磷酸盐缓冲液。

Storage Conditions and Expiration
English

Storage at 2 °C ~ 8 °C in the dark can be stable for 18 months to prevent freezing. After opening, it can be stable for 30 days when stored at 2 °C ~ 8 °C.

中文

2℃~8℃避光贮存可稳定18个月,防止冷冻。开瓶后于2℃~8℃贮存可稳定30天。