Prostate-specific antigen detection kit (chemiluminescence method)
- Device class
- Class III
- Model specifications
- 30 servings/box, 50 servings/box, 100 servings/box.30人份/盒、50人份/盒、100人份/盒。
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243402329
- Approval date
- November 21, 2024
- Expiry date
- November 20, 2029
- Name
- URIT MEDICAL Electronic Co., Ltd.桂林优利特医疗电子有限公司
- Province/Region
- Guangxi广西
- Address
- No. D-07, Information Industrial Park, Guilin High-tech Zone桂林市高新区信息产业园D-07号
- Production address
- 桂林市高新区信息产业园D-07号
用于体外定量检测人血清或血浆中总前列腺特异性抗原(tPSA)的含量.临床上主要用于对恶性肿瘤患者进行动态监测以辅助判断疾病进程或治疗效果,不能作为恶性肿瘤早期诊断或确诊的依据,不用于普通人群的肿瘤筛查.
用于体外定量检测人血清或血浆中总前列腺特异性抗原（tPSA）的含量。临床上主要用于对恶性肿瘤患者进行动态监测以辅助判断疾病进程或治疗效果，不能作为恶性肿瘤早期诊断或确诊的依据，不用于普通人群的肿瘤筛查。
本试剂盒由磁微粒、酶标试剂、校准品、质控品组成.(具体内容详见说明书)
本试剂盒由磁微粒、酶标试剂、校准品、质控品组成。（具体内容详见说明书）
2℃～8℃密封保存,有效期15个月.
2℃～8℃密封保存，有效期15个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Prostate-specific antigen detection kit (chemiluminescence method) in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243402329 and owned by URIT MEDICAL Electronic Co., Ltd.. The device was approved on November 21, 2024.
This page provides complete registration details including registrant information, province location (Guangxi), 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.