Fully automatic chemiluminescence immunoassay analyzer
- Device class
- Class II
- Model specifications
- CM3000
- Approval department
- Anhui Provincial Drug Administration安徽省药品监督管理局
- Registration number
- 皖械注准20222220180
- Approval date
- August 02, 2022
- Expiry date
- August 01, 2027
- Name
- Anhui Century Kangda Biotechnology Co., Ltd.安徽世纪康大生物科技有限公司
- Province/Region
- Anhui安徽
- Address
- Room 401, 5# Electronic Workshop, Science and Technology Innovation Center, No. 82 Huashan Road, Yingzhou Development Zone, Yingzhou District, Fuyang City阜阳市颍州区颍州开发区华山路82号科创中心5＃电子厂房401室
- Production address
- 阜阳市颍州区颍州开发区华山路82号科创中心5＃电子厂房401室
The product uses a direct chemiluminescence method based on acridine esters and is used in conjunction with the accompanying detection reagents to quantify analytes in serum, plasma, and urine samples derived from humans.
该产品采用基于吖啶酯的直接化学发光法，与配套的检测试剂共同使用，在临床上用于对来源于人体的血清、血浆、尿液样本中的被分析物进行定量检测。
The product consists mainly of the host and control software (version number V1). The host is composed of sample processing module, reagent processing module, reaction cup transport module, sample reagent dispensing module, reaction solution mixing module, reaction module and substrate module.
产品主要由主机和控制软件（版本号 V1）组成。其中主机由样本处理模块、试剂处理模块、反应杯转运模块、样本试剂分注模块、反应液混匀模块、反应模块、底物模块组成。
Access comprehensive regulatory information for Fully automatic chemiluminescence immunoassay analyzer 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20222220180 and owned by Anhui Century Kangda Biotechnology Co., Ltd.. The device was approved on August 02, 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.