China NMPA legacy archive 国械注准20243402404Total 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.
- Approval department
- State Drug Administration
- Registration number
- 国械注准20243402404
- Approval date
- November 27, 2024
- Expiry date
- November 26, 2029
- Province/Region
- Shandong
- Address
- No. 1-4, Weigao Road, Torch High-tech Industrial Development Zone, Weihai City, Shandong Province
- 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
This static archive preserves historical registration fields and translations for Total Prostate-Specific Antigen (t-PSA) Assay Kit (Magnetic Particulate Chemiluminescence), registration 国械注准20243402404. It does not establish current authorization or complete current product details.
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