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Matrix Metalloproteinase-3 Test Kit (Latex Immunoassay) - NMPA Registration 京械注准20242400127

Access comprehensive regulatory information for Matrix Metalloproteinase-3 Test Kit (Latex Immunoassay) 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20242400127 and owned by Beijing Enjihe Biological Engineering Co., Ltd.. The device was approved on March 22, 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20242400127
Matrix Metalloproteinase-3 Test Kit (Latex Immunoassay)
基质金属蛋白酶-3测定试剂盒（胶乳免疫比浊法）
NMPA Registration Number: 京械注准20242400127
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Intended Use
English

It is used for in vitro quantitative determination of matrix metalloproteinase-3 (MMP-3) content in human serum samples.

中文

用于体外定量测定人血清样本中基质金属蛋白酶-3（MMP-3）的含量。

Device Classification
Device Class
Class II
Model Specifications
试剂1:12mL; 1,试剂2:4mL; 1;试剂1:12mL; 3,试剂2:4mL; 3;试剂1:12mL; 4,试剂2:4mL; 4;试剂1:12mL; 5,试剂2:4mL; 5;试剂1:12mL; 6,试剂2:4mL; 6;试剂1:12mL; 7,试剂2:4mL; 7;试剂1:12mL; 8,试剂2:4mL; 8;试剂1:12mL; 9,试剂2:4mL; 9;试剂1:12mL; 10,试剂2:4mL; 10;试剂1:60mL; 1,试剂2:20mL; 1;试剂1:60mL; 2,试剂2:20mL; 2;试剂1:60mL; 3,试剂2:20mL; 3;试剂1:60mL; 3,试剂2:60mL; 1;试剂1:60mL; 4,试剂2:20mL; 4;试剂1:60mL; 2,试剂2:40mL; 1;试剂1:60mL; 4,试剂2:40mL; 2;试剂1:60mL; 5,试剂2:50mL; 2;试剂1:60mL; 5,试剂2:20mL; 5;试剂1:60mL; 6,试剂2:60mL; 2;试剂1:60mL; 6,试剂2:20mL; 6;试剂1:90mL; 1,试剂2:30mL; 1;试剂1:90mL; 2,试剂2:60mL; 1;试剂1:90mL; 3,试剂2:90mL; 1;试剂1:90mL; 4,试剂2:60mL; 2;试剂1:90mL; 6,试剂2:90mL; 2;试剂1:15mL; 1,试剂2:5mL; 1;试剂1:3L; 1,试剂2:1L; 1;试剂1:15L; 1,试剂2:5L; 1;试剂1:45mL; 1,试剂2:15mL; 1;试剂1:45ml; 2,试剂2:15ml; 2;校准品(6水平,选配):1mL; 6;0.5mL; 6;质控品(2水平,选配):1mL; 2;0.5mL; 2.
试剂1：12mL;1，试剂2：4mL;1；试剂1：12mL;3，试剂2：4mL;3；试剂1：12mL;4，试剂2：4mL;4；试剂1：12mL;5，试剂2：4mL;5；试剂1：12mL;6，试剂2：4mL;6；试剂1：12mL;7，试剂2：4mL;7；试剂1：12mL;8，试剂2：4mL;8；试剂1：12mL;9，试剂2：4mL;9；试剂1：12mL;10，试剂2：4mL;10；试剂1：60mL;1，试剂2：20mL;1；试剂1：60mL;2，试剂2：20mL;2；试剂1：60mL;3，试剂2：20mL;3；试剂1：60mL;3，试剂2：60mL;1；试剂1：60mL;4，试剂2：20mL;4；试剂1：60mL;2，试剂2：40mL;1；试剂1：60mL;4，试剂2：40mL;2；试剂1：60mL;5，试剂2：50mL;2；试剂1：60mL;5，试剂2：20mL;5；试剂1：60mL;6，试剂2：60mL;2；试剂1：60mL;6，试剂2：20mL;6；试剂1：90mL;1，试剂2：30mL;1；试剂1：90mL;2，试剂2：60mL;1；试剂1：90mL;3，试剂2：90mL;1；试剂1：90mL;4，试剂2：60mL;2；试剂1：90mL;6，试剂2：90mL;2；试剂1：15mL;1，试剂2：5mL;1；试剂1：3L;1，试剂2：1L;1；试剂1：15L;1，试剂2:5L;1；试剂1：45mL;1，试剂2：15mL;1；试剂1：45ml;2，试剂2：15ml;2；校准品（6水平，选配）：1mL;6；0.5mL;6；质控品（2水平，选配）：1mL;2；0.5mL;2。
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20242400127
Approval Date
March 22, 2024
Expiry Date
March 21, 2029
Registrant
Name
Beijing Enjihe Biological Engineering Co., Ltd.
乐普（北京）诊断技术股份有限公司
Province/Region
Beijing
北京
Address
205, Building 1, No. 6 Lixiang Road, Nanshao Town Science and Technology Park, Changping District, Beijing
北京市昌平区南邵镇科技园区利祥路6号1幢205
Production Facility
Production Address
北京市平谷区马坊镇盘龙西路21号院3号楼二层
Structure and Composition
English

Reagent 1: Phosphate buffer 100mmol/L, pH 8.0 Reagent 2, phosphate buffer 100mmol/L, pH 8.0 antibody sensitization latex (anti-human matrix metalloproteinase-3 antibody) > 2 ng/ml calibrator, phosphate buffer 100 mmol/L, pH 8.0 matrix metalloproteinase-3 buffer matrix, 6 levels, liquid, target concentration is level 1: 0.0 ng/mL level 2: 80.0 ~ 120.0 ng/ mL Level 3: 170.0~230.0ng/mL Level 4: 350.0~450.0ng/mL Level 5: 700.0~900.0ng/mL Level 6: 1300.0~1800.0ng/mL Quality Control Phosphate Buffer 100mmol/L, pH8.0 Matrix Metalloproteinase-3 Buffer Matrix, 2 Levels, Liquid, Target Range 1: 50.0~150.0ng/ mL level 2: 160.0~350.0ng/mL Note: The calibrator and quality control are batch-specific, and the specific concentration is shown in the target value list.

中文

试剂1磷酸盐缓冲液100mmol/L，pH8.0试剂2磷酸盐缓冲液100mmol/L，pH8.0抗体致敏胶乳（抗人基质金属蛋白酶-3抗体）＞2ng/ml校准品磷酸盐缓冲液100mmol/L，pH8.0基质金属蛋白酶-3缓冲液基质，6水平，液体，目标浓度为水平1：0.0ng/mL水平2：80.0～120.0ng/mL水平3：170.0～230.0ng/mL水平4：350.0～450.0ng/mL水平5：700.0～900.0ng/mL水平6：1300.0～1800.0ng/mL质控品磷酸盐缓冲液100mmol/L，pH8.0基质金属蛋白酶-3缓冲液基质，2水平，液体，靶值范围为水平1：50.0～150.0ng/mL水平2：160.0～350.0ng/mL注：校准品及质控品具有批特异性，具体浓度见靶值单。

Storage Conditions and Expiration
English

2 °C ~ 8 °C storage, valid for 12 months.

中文

2℃～8℃保存，有效期12个月。