Matrix Metalloproteinase-3 Test Kit (Latex Immunoassay)
- 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 number
- 京械注准20242400127
- Approval date
- March 22, 2024
- Expiry date
- March 21, 2029
- 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 address
- 北京市平谷区马坊镇盘龙西路21号院3号楼二层
It is used for in vitro quantitative determination of matrix metalloproteinase-3 (MMP-3) content in human serum samples.
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。
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.
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。
2 °C ~ 8 °C storage, valid for 12 months.
2℃～8℃保存，有效期12个月。
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.