China NMPA legacy archive 国械注准20243402329Prostate-specific antigen detection kit (chemiluminescence method)
总前列腺特异性抗原检测试剂盒（磁微粒化学发光法）
URIT MEDICAL Electronic Co., Ltd.Class IIINMPAApproved November 21, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class III
- Model specifications
- 30 servings/box, 50 servings/box, 100 servings/box.
- Approval department
- State Drug Administration
30人份/盒、50人份/盒、100人份/盒。
国家药品监督管理局
Registration information
- Registration number
- 国械注准20243402329
- Approval date
- November 21, 2024
- Expiry date
- November 20, 2029
Registrant
- Province/Region
- Guangxi
- Address
- No. D-07, Information Industrial Park, Guilin High-tech Zone
广西
桂林市高新区信息产业园D-07号
Production facility
- Production address
- 桂林市高新区信息产业园D-07号
Intended use
English
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.
中文
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。
Structure and composition
English
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)
中文
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）
Storage conditions and expiration
English
2℃～8℃密封保存,有效期15个月.
中文
2℃～8℃密封保存，有效期15个月。
Additional information
- Appendix
- 产品技术要求、说明书
About this record
This static archive preserves historical registration fields and translations for Prostate-specific antigen detection kit (chemiluminescence method), registration 国械注准20243402329. It does not establish current authorization or complete current product details.
The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.