China NMPA legacy archive 川械注准20242400312Testosterone Test Kit (Chemiluminescence Assay)
睾酮测定试剂盒（化学发光法）
Sichuan Orienter Biotechnology Co., Ltd.Class IINMPAApproved November 26, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class II
- Model specifications
- 50 测试/盒 2×50 测试/盒 4×50 测试/盒 100 测试/盒 200 测试/盒 300 测试/盒 400 测试/盒 校准品:0.5mL×2、1.0mL×2、0.5mL×3、1.0mL×3、0.5mL×6、1.0mL×6.(选配) 质控品:0.5mL×2、1.0mL×2、2.0mL×2.(选配)
- Approval department
- Sichuan Provincial Drug Administration
50 测试/盒 2×50 测试/盒 4×50 测试/盒 100 测试/盒 200 测试/盒 300 测试/盒 400 测试/盒 校准品：0.5mL×2、1.0mL×2、0.5mL×3、1.0mL×3、0.5mL×6、1.0mL×6。（选配） 质控品：0.5mL×2、1.0mL×2、2.0mL×2。（选配）
四川省药品监督管理局
Registration information
- Registration number
- 川械注准20242400312
- Approval date
- November 26, 2024
- Expiry date
- November 25, 2029
Registrant
- Province/Region
- Sichuan
- Address
- No. 9, Kangqiang 4th Road, Chengdu High-tech Zone
四川
成都高新区康强四路9号
Production facility
- Production address
- 成都高新区康强四路9号W2、W7
Intended use
English
本试剂盒用于体外定量测定人血清或血浆样本中睾酮(Testosterone,T)的浓度.
中文
本试剂盒用于体外定量测定人血清或血浆样本中睾酮（Testosterone,T）的浓度。
Structure and composition
English
试剂1(R1):免疫磁珠;试剂2(R2):酶结合物;试剂3(R3):分析缓冲液 ;T校准品;T质控品.(具体内容详见产品说明书)
中文
试剂1（R1）：免疫磁珠；试剂2（R2）：酶结合物；试剂3（R3）：分析缓冲液 ；T校准品；T质控品。（具体内容详见产品说明书）
Storage conditions and expiration
English
2°C~8°C sealed and protected from light, and the validity period is 15 months.
中文
2℃～8℃密闭避光保存有效期为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 Testosterone Test Kit (Chemiluminescence Assay), registration 川械注准20242400312. 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.