Thyroid-related autoantibody quality control material
- Device class
- Class II
- Model specifications
- L:3×3.0 mL、H:3×3.0 mLL：3×3.0 mL、H：3×3.0 mL
- Approval department
- Guangdong Provincial Drug Administration广东省药品监督管理局
- Registration number
- 粤械注准20252400157
- Approval date
- January 23, 2025
- Expiry date
- January 22, 2030
- Name
- Medcaptain MEDICAL Technology Co., Ltd.深圳麦科田生物医疗技术股份有限公司
- Province/Region
- Guangdong广东
- Address
- 12th floor, Building 1, Baiwang R&D Building, No. 5158 West Xilishahe West Road, Nanshan District, Shenzhen深圳市南山区西丽沙河西路5158号百旺研发大厦1栋第12层
- Production address
- 深圳市光明区马田街道佳乐科技工业园厂房C栋
该产品配合深圳麦科田生物医疗技术股份有限公司的抗甲状腺过氧化物酶抗体（Anti-TPO）测定试剂盒（化学发光免疫分析法）、抗甲状腺球蛋白抗体（Anti-TG）测定试剂盒（化学发光免疫分析法）、促甲状腺激素受体抗体（Anti-TSHR）测定试剂盒（化学发光免疫分析法），用于抗甲状腺过氧化物酶抗体（Anti-TPO）、抗甲状腺球蛋白抗体（Anti-TG）、促甲状腺激素受体抗体（Anti-TSHR）项目的质量控制。
甲状腺相关自身抗体质控品L：低浓度抗甲状腺过氧化物酶抗体（小鼠）/抗甲状腺球蛋白抗体（小鼠）/促甲状腺激素受体抗体（小鼠）；MOPS缓冲液；ProClin 300； 甲状腺相关自身抗体质控品H：高浓度抗甲状腺过氧化物酶抗体（小鼠）/抗甲状腺球蛋白抗体（小鼠）/促甲状腺激素受体抗体（小鼠）；MOPS缓冲液；ProClin 300； 复溶剂：纯化水； 靶值卡：包含质控品靶值及质控品信息。
储存条件：应在2～8℃环境下，密封保存，避免冷冻。有效期：16个月。 复溶后，在常温（10～30℃）条件下，有效期24小时；在2～8℃环境下，有效期5天；在-20℃环境下，有效期60天，仅可冻融1次。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Thyroid-related autoantibody quality control material in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20252400157 and owned by Medcaptain MEDICAL Technology Co., Ltd.. The device was approved on January 23, 2025.
This page provides complete registration details including registrant information, province location (Guangdong), 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.