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Chylomicron E determination reagent kit (latex-enhanced immune turbidimetry method) - NMPA Registration 京械注准20242400448

Access comprehensive regulatory information for Chylomicron E determination reagent kit (latex-enhanced immune turbidimetry 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 京械注准20242400448 and owned by Beijing Bioassay Technologies Corporation. The device was approved on August 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20242400448
Chylomicron E determination reagent kit (latex-enhanced immune turbidimetry method)
载脂蛋白E测定试剂盒(胶乳免疫比浊法)
NMPA Registration Number: 京械注准20242400448
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Intended Use
English

It is used for the quantitative determination of apolipoprotein E (ApoE) content in human serum and plasma in vitro.

中文

用于体外定量测定人血清、血浆中载脂蛋白E(ApoE)的含量。

Device Classification
Device Class
Class II
Model Specifications
试剂1:16mL; 1,试剂2:4mL; 1试剂1:16mL; 2,试剂2:4mL; 2试剂1:16mL; 3,试剂2:4mL; 3试剂1:16mL; 8,试剂2:4mL; 8试剂1:20mL; 8,试剂2:5mL; 8试剂1:40mL; 1,试剂2:10mL; 1试剂1:40mL; 2,试剂2:10mL; 2试剂1:40mL; 3,试剂2:15mL; 2试剂1:40mL; 4,试剂2:40mL; 1试剂1:48mL; 2,试剂2:12mL; 2试剂1:48mL; 3,试剂2:12mL; 3试剂1:48mL; 4,试剂2:12mL; 4试剂1:48mL; 2,试剂2:24mL; 1试剂1:48mL; 4,试剂2:24mL; 2试剂1:50mL; 2,试剂2:25mL; 1试剂1:50mL; 4,试剂2:25mL; 2试剂1:50mL; 4,试剂2:50mL; 1试剂1:60mL; 1,试剂2:15mL; 1试剂1:60mL; 2,试剂2:15mL; 2试剂1:60mL; 3,试剂2:15mL; 3试剂1:60mL; 3,试剂2:45mL; 1试剂1:60mL; 6,试剂2:45mL; 2试剂1:60mL; 4,试剂2:60mL; 1试剂1:80mL; 1,试剂2:20mL; 1试剂1:80mL; 2,试剂2:20mL; 2试剂1:80mL; 3,试剂2:20mL; 3试剂1:80mL; 4,试剂2:20mL; 4试剂1:100mL; 4,试剂2:100mL; 1试剂1:4L; 1,试剂2:1L; 1试剂1:5L; 4,试剂2:5L; 1试剂1:5L; 8,试剂2:5L; 2试剂1:20mL; 1,试剂2:5mL; 1校准品(选配):1.0mL; 1;1.0mL; 2;1.0mL; 5;1.0mL; 10. 质控品(选配):水平1:1.0mL; 1;1.0mL; 2;1.0mL; 5;1.0mL; 10. 水平2:1.0mL; 1;1.0mL; 2;1.0mL; 5;1.0mL; 10.
试剂1:16mL;1,试剂2:4mL;1试剂1:16mL;2,试剂2:4mL;2试剂1:16mL;3,试剂2:4mL;3试剂1:16mL;8,试剂2:4mL;8试剂1:20mL;8,试剂2:5mL;8试剂1:40mL;1,试剂2:10mL;1试剂1:40mL;2,试剂2:10mL;2试剂1:40mL;3,试剂2:15mL;2试剂1:40mL;4,试剂2:40mL;1试剂1:48mL;2,试剂2:12mL;2试剂1:48mL;3,试剂2:12mL;3试剂1:48mL;4,试剂2:12mL;4试剂1:48mL;2,试剂2:24mL;1试剂1:48mL;4,试剂2:24mL;2试剂1:50mL;2,试剂2:25mL;1试剂1:50mL;4,试剂2:25mL;2试剂1:50mL;4,试剂2:50mL;1试剂1:60mL;1,试剂2:15mL;1试剂1:60mL;2,试剂2:15mL;2试剂1:60mL;3,试剂2:15mL;3试剂1:60mL;3,试剂2:45mL;1试剂1:60mL;6,试剂2:45mL;2试剂1:60mL;4,试剂2:60mL;1试剂1:80mL;1,试剂2:20mL;1试剂1:80mL;2,试剂2:20mL;2试剂1:80mL;3,试剂2:20mL;3试剂1:80mL;4,试剂2:20mL;4试剂1:100mL;4,试剂2:100mL;1试剂1:4L;1,试剂2:1L;1试剂1:5L;4,试剂2:5L;1试剂1:5L;8,试剂2:5L;2试剂1:20mL;1,试剂2:5mL;1校准品(选配):1.0mL;1;1.0mL;2;1.0mL;5;1.0mL;10。质控品(选配):水平1:1.0mL;1;1.0mL;2;1.0mL;5;1.0mL;10。水平2:1.0mL;1;1.0mL;2;1.0mL;5;1.0mL;10。
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20242400448
Approval Date
August 22, 2024
Expiry Date
August 21, 2029
Registrant
Name
Beijing Bioassay Technologies Corporation
北京世纪沃德生物科技有限公司
Province/Region
Beijing
北京
Address
401, 4th floor, 4th floor, No. 21, Torch Street, Science and Technology Park, Changping District, Beijing
北京市昌平区科技园区火炬街21号4幢4层401
Production Facility
Production Address
北京市昌平区火炬街28号1号楼一层东侧,北京市中关村科技园昌平园火炬街28号1号楼一层西侧B区
Structure and Composition
English

Composition: Main components: Concentration: Reagent 1 (R1): Liquid sodium citrate: 100mmol/L, sodium chloride, 0.15mol/L, preservative, 0.03%, Reagent 2 (R2), liquid sodium citrate: 100mmol/L, bovine serum albumin, 1% Tween 201%, preservative: 0.03%, coated with anti-apolipoprotein E antibody, latex particles, 0.5% calibrator (optional), lyophilized powder, phosphate buffer, 20mmol/L, preservative: 0.03%, protectant: 5%, sodium chloride: 0.15mol/ L apolipoprotein E target concentration range: (12.00, 18.00) mg/dL quality control (optional) lyophilized powder, phosphate buffer 20mmol/L, preservative, 0.03%, protective agent, 5% sodium chloride, 0.15mol/L, apolipoprotein E, target concentration range: level 1: (1.00, 6.00) mg/dL, level 2: (6.00, 12.00) mg/dL, calibrator target value batch specific, see calibrator bottle label for details; The quality control and quality control scope are specific to each batch, please refer to the quality control bottle label for details. Calibrators are traceable to corporate work calibrators. The components are not interchangeable in different lot number kits.

中文

组成性状主要成分浓度试剂1(R1)液体柠檬酸钠100mmol/L氯化钠0.15mol/L防腐剂0.03%试剂2(R2)液体柠檬酸钠100mmol/L牛血清白蛋白1%吐温201%防腐剂0.03%包被有抗载脂蛋白E抗体胶乳颗粒0.5%校准品(选配)冻干粉磷酸盐缓冲液20mmol/L防腐剂0.03%保护剂5%氯化钠0.15mol/L载脂蛋白E靶值浓度范围:(12.00,18.00)mg/dL质控品(选配)冻干粉磷酸盐缓冲液20mmol/L防腐剂0.03%保护剂5%氯化钠0.15mol/L载脂蛋白E目标浓度范围:水平1:(1.00,6.00)mg/dL水平2:(6.00,12.00)mg/dL校准品靶值批特异,详见校准品瓶签;质控品质控范围批特异,详见质控品瓶签。校准品溯源至企业工作校准品。不同批号试剂盒中各组分不能互换。

Storage Conditions and Expiration
English

Store at 2°C~8°C in the dark, valid for 18 months.

中文

2℃~8℃避光保存,有效期为18个月。