Ischemically modified albumin detection reagent kit (albumin-cobalt binding test method) - NMPA Registration 渝械注准20162400070

Access comprehensive regulatory information for Ischemically modified albumin detection reagent kit (albumin-cobalt binding test 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 渝械注准20162400070 and owned by Chongqing Zhongyuan BIO-TECHNOLOGY Co., Ltd.. The device was approved on October 15, 2021.

This page provides complete registration details including registrant information, province location (Chongqing), 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

渝械注准20162400070

Ischemically modified albumin detection reagent kit (albumin-cobalt binding test method)

缺血修饰白蛋白检测试剂盒（白蛋白-钴结合试验法）

NMPA Registration Number: 渝械注准20162400070

DJ Fang

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Intended Use

English

This reagent is suitable for the determination of ischemia-modified albumin content in human serum or plasma samples.

中文

本试剂适用于人血清或血浆样本中缺血修饰白蛋白含量的测定。

Device Classification

Device Class

Class II

Model Specifications

R1 and R2 are liquid reagents R1:60 mL×1, R2:30 mL×1; R1:60 mL×2, R2:30 mL×2; R1:40 mL×1, R2:20 mL×1; R1:40 mL×2, R2:20 mL×2; R1:30mL×1 R2:15mL×1 R1:30mL×3 R2:15mL×3 R1:24 mL×1, R2:12 mL×1; R1:24 mL×2, R2:12 mL×2; R1:12 mL×3, R2:6 mL×3. Servings: 48T×6;64T×6;100T×2;170T×2;200T×2; 300T×2;400T×2;500T×2. Calibrator 1: Liquid reagent Concentration is indicated on the bottle label, 1.0 or 0.6 mL Calibrator 2: Liquid reagent Concentration is indicated on the bottle label, 1.0 or 0.6 mL Controls (optional): 1 stick × 1.0 mL

R1、R2均为液体试剂 R1：60 mL×1， R2：30 mL×1； R1：60 mL×2， R2：30 mL×2； R1：40 mL×1， R2：20 mL×1； R1：40 mL×2， R2：20 mL×2； R1：30mL×1 R2：15mL×1 R1：30mL×3 R2：15mL×3 R1：24 mL×1， R2：12 mL×1； R1：24 mL×2， R2：12 mL×2; R1：12 mL×3， R2：6 mL×3。人份：48T×6；64T×6；100T×2；170T×2；200T×2； 300T×2；400T×2；500T×2。校准品1：液体试剂浓度见瓶身标签，1.0或0.6 mL 校准品2：液体试剂浓度见瓶身标签，1.0或0.6 mL 质控品（选配）：1支×1.0 mL

Approval Department

Chongqing Municipal Drug Administration

重庆市药品监督管理局

Registration Information

Registration Number

渝械注准20162400070

Approval Date

October 15, 2021

Expiry Date

April 22, 2026

Registrant

Name

Chongqing Zhongyuan BIO-TECHNOLOGY Co., Ltd.

重庆中元生物技术有限公司

Province/Region

Chongqing

重庆

Address

3rd floor, Block J, No. 70-1, 70-2, Keyuan 4th Street, Jiulongpo District, Chongqing

重庆市九龙坡区科园四街70-1、70-2号J座3层

Production Facility

Production Address

重庆市大渡口区建桥工业园C区太康路10号27-28栋第1-4层

Structure and Composition

English

R1: Cobalt chloride 0.01%; phosphate buffer solution 0.05mol/L; Proclin300 0.03%; R2: Dithiothreitol (DTT) 1.5mg/ml; Proclin300 0.03%; Ischemia-modified albumin calibrator: see the bottle label for each batch of fixed value; Human serum albumin Human serum albumin used to make calibrators is negative for HIV, HCV antibodies, and HBs antigens, but safety is recommended as a potential contagion. Calibrator concentration traceability to the International Chemical Union (IFCC) standard reference method.

中文

R1：氯化钴 0.01%；磷酸盐缓冲溶液 0.05mol/L；Proclin300 0.03%；R2：二硫苏糖醇（DTT） 1.5mg/ml；Proclin300 0.03%；缺血修饰白蛋白校准品：每批定值见瓶签；人血清白蛋白用于制作校准品的人血清白蛋白经检测HIV、HCV抗体和HBs抗原结果为阴性，但考虑到安全性建议按潜在传染物来处理。校准品浓度溯源至国际化学联合会（IFCC）的标准参考方法。

Storage Conditions and Expiration

English

The reagent is stored in a dark environment at 2 °C ~ 8 °C and the validity period is 12 months. After opening the package, it can be stored for 1 month in a dark environment at 2°C~8°C. To ensure the accuracy of results, the control should only be used on the same day after reconstitution.

中文

试剂储存于2℃～8℃避光环境中，有效期为12个月。打开包装后，2℃～8℃避光环境中可保存1个月。为确保结果准确性，质控品复溶后仅限当天使用。

Additional Information

Appendix

产品技术要求