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Urinary protein complex calibration - NMPA Registration 皖械注准20242400155

Access comprehensive regulatory information for Urinary protein complex calibration 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20242400155 and owned by Anhui Iprocom Biotechnology Co., Ltd.. The device was approved on September 21, 2024.

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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NMPA Official Data
Class II
皖械注准20242400155
Urinary protein complex calibration
尿液蛋白复合校准品
NMPA Registration Number: 皖械注准20242400155
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Pricing
Intended Use
English

This product is used as a calibrator for the analysis of urine protein items, and contains 8 items. Test items: retinol-binding protein, α1-microglobulin, transferrin, urine microalbumin, β2-microglobulin, urine α2 macroglobulin, urinary cystatin C, neutrophil gelatinase-related lipocarrierin.

中文

本品作为尿液蛋白项目分析校准品使用,包含8个项目。 检验项目:视黄醇结合蛋白、α1-微球蛋白、转铁蛋白、尿微量白蛋白、β2-微球蛋白、尿α2巨球蛋白、尿胱抑素C、中性粒细胞明胶酶相关脂质运载蛋白。

Device Classification
Device Class
Class II
Model Specifications
6×0.5mL、6×1mL、6×3mL、6×5mL
Approval Department
Anhui Provincial Drug Administration
安徽省药品监督管理局
Registration Information
Registration Number
皖械注准20242400155
Approval Date
September 21, 2024
Expiry Date
September 20, 2029
Registrant
Name
Anhui Iprocom Biotechnology Co., Ltd.
安徽伊普诺康生物技术股份有限公司
Province/Region
Anhui
安徽
Address
No. 659, Lanzhou Road, Baohe District, Hefei
合肥市包河区兰州路659号
Production Facility
Production Address
合肥市包河区兰州路659号
Structure and Composition
English

Trimethylolaminomethane, bovine serum albumin, retinol-binding protein antigen, alpha-1 microglobulin antigen, transferrin antigen, microalbumin, beta-2 microglobulin antigen, alpha-2 macroglobulin antigen, cystatin C antigen, neutrophil gelatinase-associated lipocarbin antigen

中文

三羟甲基氨基甲烷、牛血清白蛋白、视黄醇结合蛋白抗原、α1微球蛋白抗原、转铁蛋白抗原、微量白蛋白、β2微球蛋白抗原、α2巨球蛋白抗原、胱抑素C抗原,中性粒细胞明胶酶相关脂质运载蛋白抗原

Storage Conditions and Expiration
English

1. The unopened calibrator should be sealed at 2°C ~ 8°C and stored in the dark, and the validity period is 12 months; 2. After opening the bottle, the calibrator is stored at 2°C ~ 8°C away from light, pay attention to volatilization, and the validity period is 7 days.

中文

1.未开封的校准品在2℃ ~ 8℃密封避光保存,有效期12个月; 2.开瓶后的校准品2℃ ~ 8℃避光保存,注意挥发,有效期7天。

Additional Information
Appendix
产品技术要求、说明书