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Adiponectin assay kit (latex immunoturbidimetry) - NMPA Registration 京械注准20242400731

Access comprehensive regulatory information for Adiponectin assay kit (latex immunoturbidimetry) 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20242400731 and owned by Biosino BIO-TECHNOLOGY and Science INC.. The device was approved on November 26, 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20242400731
Adiponectin assay kit (latex immunoturbidimetry)
脂联素测定试剂盒（胶乳免疫比浊法）
NMPA Registration Number: 京械注准20242400731
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Intended Use
English

用于体外定量测定人血清或血浆中脂联素(ADPN)的浓度.

中文

用于体外定量测定人血清或血浆中脂联素（ADPN）的浓度。

Device Classification
Device Class
Class II
Model Specifications
试剂1(R1):20mL;1,试剂2(R2):5mL;1;试剂1(R1):40mL;1,试剂2(R2):10mL;1;试剂1(R1):60mL;1,试剂2(R2):15mL;1;试剂1(R1):60mL;2,试剂2(R2):15mL;2;260测试/盒;280测试/盒;300测试/盒;450测试/盒;校准品:1mL;1;质控品:水平1:1mL;1;水平2:1mL;1.
试剂1（R1）：20mL;1，试剂2（R2）：5mL;1；试剂1（R1）：40mL;1，试剂2（R2）：10mL;1；试剂1（R1）：60mL;1，试剂2（R2）：15mL;1；试剂1（R1）：60mL;2，试剂2（R2）：15mL;2；260测试/盒；280测试/盒；300测试/盒；450测试/盒；校准品：1mL;1；质控品：水平1：1mL;1；水平2：1mL;1。
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20242400731
Approval Date
November 26, 2024
Expiry Date
November 25, 2029
Registrant
Name
Biosino BIO-TECHNOLOGY and Science INC.
中生北控生物科技股份有限公司
Province/Region
Beijing
北京
Address
No. 27, Chaoqian Road, Science and Technology Park, Changping District, Beijing
北京市昌平区科技园区超前路27号
Production Facility
Production Address
北京市昌平区科技园区超前路27号
Structure and Composition
English

1.试剂1(R1)甘氨酸缓冲液(pH7.0)100mmol/L2.试剂2(R2)包被脂联素抗体的胶乳颗粒0.2w/v%3.校准品(冻干粉)人血清基质(血清含量为50%),目标浓度范围为30.00mg/L～50.00mg/L,脂联素抗原来自基因工程菌表达.每批定值,值有批特异性,详见值单.4.质控品(冻干粉)人血清基质(血清含量为50%),两水平,浓度范围分别为水平1:2.00mg/L～7.00mg/L,水平2:8.00mg/L～25.00mg/L,脂联素抗原来自基因工程菌表达.每批定值,值有批特异性,详见值单.

中文

1.试剂1（R1）甘氨酸缓冲液（pH7.0）100mmol/L2.试剂2（R2）包被脂联素抗体的胶乳颗粒0.2w/v%3.校准品（冻干粉）人血清基质（血清含量为50%），目标浓度范围为30.00mg/L～50.00mg/L，脂联素抗原来自基因工程菌表达。每批定值，值有批特异性，详见值单。4.质控品（冻干粉）人血清基质（血清含量为50%），两水平，浓度范围分别为水平1：2.00mg/L～7.00mg/L，水平2：8.00mg/L～25.00mg/L，脂联素抗原来自基因工程菌表达。每批定值，值有批特异性，详见值单。

Storage Conditions and Expiration
English

2 °C ~ 8 °C stored in the dark, valid for 12 months.

中文

2℃～8℃避光贮存，有效期12个月。