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Leptin (ADP) Determination Reagent Kit (Latex Immunoturbidimetric Method) - NMPA Registration 京械注准20232400500

Access comprehensive regulatory information for Leptin (ADP) Determination Reagent Kit (Latex 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 京械注准20232400500 and owned by Beijing Baiao Taikang Biotechnology Co., Ltd.. The device was approved on August 07, 2023.

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20232400500
Leptin (ADP) Determination Reagent Kit (Latex Immunoturbidimetric Method)
脂联素（ADP）测定试剂盒（胶乳免疫比浊法）
NMPA Registration Number: 京械注准20232400500
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Intended Use
English

This kit is used for the in vitro quantitative determination of adiponectin concentrations in human serum.

中文

该试剂盒用于体外定量测定人血清中脂联素浓度。

Device Classification
Device Class
Class II
Model Specifications
Reagent 1: 20mL times; 1, Reagent 2: 5mLtimes; 1; Reagent 1: 60mL times; 1, Reagent 2: 15mL times; 1; Reagent 1: 60mL times; 2, Reagent 2: 15mLtimes; 2; Reagent 1: 90mL times; 2, Reagent 2: 23mLtimes; 2; Reagent 1: 5000mL times; 1, Reagent 2: 1250mLtimes; 1; 450 test/box;600 test/box;750 test/box;900 test/box; Calibrator (optional): 1mLtimes; 6 (6 levels); Control low value (optional): 1mLtimes; 1. High value of quality control (optional): 1mLtimes; 1.
试剂1：20mLtimes;1，试剂2：5mLtimes;1； 试剂1：60mLtimes;1，试剂2：15mLtimes;1； 试剂1：60mLtimes;2，试剂2：15mLtimes;2； 试剂1：90mLtimes;2，试剂2：23mLtimes;2； 试剂1：5000mLtimes;1，试剂2：1250mLtimes;1； 450测试/盒；600测试/盒；750测试/盒；900测试/盒； 校准品(选配):1mLtimes;6（6水平）； 质控品低值(选配):1mLtimes;1；质控品高值(选配):1mLtimes;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20232400500
Approval Date
August 07, 2023
Expiry Date
August 06, 2028
Registrant
Name
Beijing Baiao Taikang Biotechnology Co., Ltd.
北京安图生物工程有限公司
Province/Region
Beijing
北京
Address
Building 17 and Building 18, No. 13 Mintai Road, Beiwu Town, Shunyi District, Beijing (Science and Technology Innovation Functional Area)
北京市顺义区北务镇民泰路13号院17号楼、18号楼(科技创新功能区)
Production Facility
Production Address
北京市顺义区北务镇民泰路13号院17号楼、18号楼、24号楼（科技创新功能区）
Structure and Composition
English

The target value of the calibrator and the quality control range of the quality control are batch specific, see the bottle label for details.

中文

校准品靶值、质控品质控范围具有批特异性，详见瓶签。

Additional Information
Appendix
产品技术要求、说明书