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Leptin Assay Kit (Latex-Enhanced Immunoturbidimetric Method) - NMPA Registration 皖械注准20222400112

Access comprehensive regulatory information for Leptin Assay Kit (Latex-Enhanced 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 皖械注准20222400112 and owned by Anhui Daqian Bio-Engineering Limited Company. The device was approved on May 24, 2022.

This page provides complete registration details including registrant information, province location (Anhui), 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
皖械注准20222400112
Leptin Assay Kit (Latex-Enhanced Immunoturbidimetric Method)
脂联素测定试剂盒(胶乳增强免疫比浊法)
NMPA Registration Number: 皖械注准20222400112
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Intended Use
English

For in vitro quantitative detection of adiponectin (ADPN) content in human serum.

中文

用于体外定量检测人血清中脂联素(ADPN)的含量。

Device Classification
Device Class
Class II
Approval Department
Anhui Provincial Drug Administration
安徽省药品监督管理局
Registration Information
Registration Number
皖械注准20222400112
Approval Date
May 24, 2022
Expiry Date
May 23, 2027
Registrant
Name
Anhui Daqian Bio-Engineering Limited Company
安徽大千生物工程有限公司
Province/Region
Anhui
安徽
Address
Anhui Province Hefei City Economic Development District Taohua Industrial Park prosperous Avenue Industrial Investment Liheng Industrial Plaza B12C
安徽省合肥市经开区桃花工业园繁华大道工投·立恒工业广场B12C
Production Facility
Production Address
安徽省合肥市经开区桃花工业园繁华大道工投·立恒工业广场B12C
Structure and Composition
English

Reagent 1 (R1): TRIS buffer 100 mmol/L; Reagent 2 (R2) :P BS buffer 100 mmol/L; Anti-human adiponectin antibody latex granules 3.2%; Calibrator (optional): adiponectin, phosphate buffer; Controls (optional): adiponectin, phosphate buffer.

中文

试剂1(R1):TRIS缓冲液 100 mmol/L;试剂2(R2):PBS缓冲液 100 mmol/L;抗人脂联素抗体胶乳颗粒 3.2%;校准品(选配):脂联素,磷酸盐缓冲液;质控品(选配):脂联素,磷酸盐缓冲液。

Storage Conditions and Expiration
English

Storage at 2 °C ~ 8 °C in the dark can be stable for 18 months to prevent freezing. After opening, it can be stable for 30 days when stored at 2 °C ~ 8 °C.

中文

2℃~8℃避光贮存可稳定18个月,防止冷冻。开瓶后于2℃~8℃贮存可稳定30天。