Urinary Protein Complex Quality Control - NMPA Registration 皖械注准20242400160

Access comprehensive regulatory information for Urinary Protein Complex Quality Control 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20242400160 and owned by Anhui Iprocom Biotechnology Co., Ltd.. The device was approved on October 04, 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.

Free Database

NMPA Official Data

Class II

皖械注准20242400160

Urinary Protein Complex Quality Control

尿液蛋白复合质控品

NMPA Registration Number: 皖械注准20242400160

DJ Fang

MedTech Regulatory Expert

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Pricing

Intended Use

English

This product is used as a quality control for urine protein item analysis 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质控品使用，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

水平1: 1×0.5mL、1×1mL、1×3mL、1×5mL 6×0.5mL、6×1mL、6×3mL、6×5mL 10×0.5mL、10×1mL、10×3mL、10×5mL 20×0.5mL、20×1mL、20×3mL、20×5mL 水平2: 1×0.5mL、1×1mL、1×3mL、1×5mL 6×0.5mL、6×1mL、6×3mL、6×5mL 10×0.5mL、10×1mL、10×3mL、10×5mL 20×0.5mL、20×1mL、20×3mL、20×5mL 水平1、2: 水平1: 1×0.5mL、1×1mL、1×3mL、1×5mL 6×0.5mL、6×1mL、6×3mL、6×5mL 10×0.5mL、10×1mL、10×3mL、10×5mL 20×0.5mL、20×1mL、20×3mL、20×5mL 水平2: 1×0.5mL、1×1mL、1×3mL、1×5mL 6×0.5mL、6×1mL、6×3mL、6×5mL 10×0.5mL、10×1mL、10×3mL、10×5mL 20×0.5mL、20×1mL、20×3mL、20×5mL

水平1： 1×0.5mL、1×1mL、1×3mL、1×5mL 6×0.5mL、6×1mL、6×3mL、6×5mL 10×0.5mL、10×1mL、10×3mL、10×5mL 20×0.5mL、20×1mL、20×3mL、20×5mL 水平2： 1×0.5mL、1×1mL、1×3mL、1×5mL 6×0.5mL、6×1mL、6×3mL、6×5mL 10×0.5mL、10×1mL、10×3mL、10×5mL 20×0.5mL、20×1mL、20×3mL、20×5mL 水平1、2：水平1： 1×0.5mL、1×1mL、1×3mL、1×5mL 6×0.5mL、6×1mL、6×3mL、6×5mL 10×0.5mL、10×1mL、10×3mL、10×5mL 20×0.5mL、20×1mL、20×3mL、20×5mL 水平2： 1×0.5mL、1×1mL、1×3mL、1×5mL 6×0.5mL、6×1mL、6×3mL、6×5mL 10×0.5mL、10×1mL、10×3mL、10×5mL 20×0.5mL、20×1mL、20×3mL、20×5mL

Approval Department

Anhui Provincial Drug Administration

安徽省药品监督管理局

Registration Information

Registration Number

皖械注准20242400160

Approval Date

October 04, 2024

Expiry Date

October 03, 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 quality control is sealed and stored at 2°C ~ 8°C and protected from light, with an expiration date of 12 months; 2. After opening the bottle, the quality control should be stored at 2 °C ~ 8 °C in the dark, pay attention to volatilization, and be valid for 7 days.

中文

1.未开封的质控品在2℃ ~ 8℃密封避光保存，有效期12个月； 2.开瓶后的质控品在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