Total Prostate-Specific Antigen (t-PSA) Assay Kit (Magnetic Particulate Chemiluminescence)
- Device class
- Class III
- Model specifications
- 1×50 servings/box, 2×50 servings/box, 1×100 servings/box, 2×100 servings/box.1×50人份/盒、2×50人份/盒、1×100人份/盒、2×100人份/盒。
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243402404
- Approval date
- November 27, 2024
- Expiry date
- November 26, 2029
- Name
- Weihai Weigao BIOTECHNOLOGY Co., Ltd.威海威高生物科技有限公司
- Province/Region
- Shandong山东
- Address
- No. 1-4, Weigao Road, Torch High-tech Industrial Development Zone, Weihai City, Shandong Province山东省威海市火炬高技术产业开发区威高路1-4号
- Production address
- 山东省威海临港经济技术开发区棋山路566号
本产品用于体外定量检测人血清或血浆中的总前列腺特异性抗原(t-PSA)的含量.临床上主要用于前列腺癌的治疗监测,不能作为恶性肿瘤早期诊断或确诊的依据,不宜用于普通人群的肿瘤筛查.
本产品用于体外定量检测人血清或血浆中的总前列腺特异性抗原（t-PSA）的含量。临床上主要用于前列腺癌的治疗监测，不能作为恶性肿瘤早期诊断或确诊的依据，不宜用于普通人群的肿瘤筛查。
测前列腺特异性抗原磁微粒、分析缓冲液、测前列腺特异性抗原示踪结合物、校准品1、校准品2、样本稀释液、质控品.(具体内容详见说明书)
测前列腺特异性抗原磁微粒、分析缓冲液、测前列腺特异性抗原示踪结合物、校准品1、校准品2、样本稀释液、质控品。（具体内容详见说明书）
Store at 2~8°C, valid for 12 months.
2~8℃保存，有效期12个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Total Prostate-Specific Antigen (t-PSA) Assay Kit (Magnetic Particulate Chemiluminescence) 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20243402404 and owned by Weihai Weigao BIOTECHNOLOGY Co., Ltd.. The device was approved on November 27, 2024.
This page provides complete registration details including registrant information, province location (Shandong), 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.