抗甲状腺微粒体抗体检测试剂盒(化学发光微粒子免疫检测法)
- Device class
- Class II
- Model specifications
- 50 tests/box; 100 tests/box; 200 tests/box; 400 tests/box.50测试/盒；100测试/盒；200测试/盒；400测试/盒。
- Approval department
- Zhejiang Provincial Drug Administration浙江省药品监督管理局
- Registration number
- 浙械注准20242401931
- Approval date
- October 25, 2024
- Expiry date
- October 24, 2029
- Name
- Medicalsystem Biotechnology Co., Ltd.美康生物科技股份有限公司
- Province/Region
- Zhejiang浙江
- Address
- No. 299, Qiming South Road, Yinzhou District, Ningbo宁波市鄞州区启明南路299号
- Production address
- 宁波市鄞州区下应街道金达南路1228号
用于体外定量测定人血清中抗甲状腺微粒体抗体的浓度.
用于体外定量测定人血清中抗甲状腺微粒体抗体的浓度。
标记试剂、固相试剂、校准品1、校准品2、质控品1、质控品2、样本稀释液.(具体内容详见说明书)
标记试剂、固相试剂、校准品1、校准品2、质控品1、质控品2、样本稀释液。（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 抗甲状腺微粒体抗体检测试剂盒(化学发光微粒子免疫检测法) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 浙械注准20242401931 and owned by Medicalsystem Biotechnology Co., Ltd.. The device was approved on October 25, 2024.
This page provides complete registration details including registrant information, province location (Zhejiang), 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.