高尔基体蛋白73测定试剂盒(化学发光法)
- Device class
- Class II
- Model specifications
- See annex.见附件。
- Approval department
- Sichuan Provincial Drug Administration四川省药品监督管理局
- Registration number
- 川械注准20242400282
- Approval date
- November 14, 2024
- Expiry date
- November 13, 2029
- Name
- Sichuan Orienter Biotechnology Co., Ltd.四川沃文特生物技术有限公司
- Province/Region
- Sichuan四川
- Address
- No. 9, Kangqiang 4th Road, Chengdu High-tech Zone成都高新区康强四路9号
- Production address
- 成都高新区康强四路9号W2、W7；成都高新区康强四路9号W2、W7
本试剂盒用于体外定量测定人血清或血浆样本中高尔基体蛋白73(GP73)的浓度.
本试剂盒用于体外定量测定人血清或血浆样本中高尔基体蛋白73（GP73）的浓度。
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 ;GP73校准品;GP73质控品.(具体内容详见产品说明书)
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 ；GP73校准品；GP73质控品。（具体内容详见产品说明书）
2°C~8°C sealed and protected from light, and the validity period is 15 months.
2℃～8℃密闭避光保存有效期为15个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for 高尔基体蛋白73测定试剂盒(化学发光法) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 川械注准20242400282 and owned by Sichuan Orienter Biotechnology Co., Ltd.. The device was approved on November 14, 2024.
This page provides complete registration details including registrant information, province location (Sichuan), 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.