Free thyroxine detection kit (magnetic particle chemiluminescence immunoassay)
- Device class
- Class II
- Model specifications
- 100 servings/box; 200 servings/box; Calibrator (3 levels): 3; 0.5mL,3; 1mL; Controls (2 levels): 2; 0.5mL,2; 1mL.100人份/盒；200人份/盒；校准品（3水平）：3;0.5mL，3;1mL；质控品（2水平）：2;0.5mL，2;1mL。
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20242400556
- Approval date
- October 18, 2024
- Expiry date
- October 17, 2029
- Name
- Baiding Biological Engineering (Beijing) Co., Ltd.柏定生物工程（北京）有限公司
- Province/Region
- Beijing北京
- Address
- No. 11, Dongying Road, Zhaoquanying Town, Shunyi District, Beijing北京市顺义区赵全营镇兆丰产业基地东盈路11号
- Production address
- 北京市顺义区赵全营镇兆丰产业基地东盈路11号
It is used for the quantitative determination of free thyroxine content in human serum in vitro.
用于体外定量测定人血清中游离甲状腺素的含量。
名称主要组分浓度试剂1磷酸盐(PBS)缓冲液包被鼠源性甲状腺素单克隆抗体的免疫磁性微球0.05mol/L,pH7.4＞0.01%试剂2磷酸盐(PBS)缓冲液吖啶酯标记的甲状腺素抗原0.05mol/L,pH7.4＞10ng/mL校准品(液体,3水平)三羟甲基氨基甲烷(Tris)缓冲液纯化人甲状腺素0.02mol/L,pH7.4水平1目标浓度:0pmol/L水平2目标浓度:10pmol/L水平3目标浓度:40pmol/L质控品(液体,2水平)三羟甲基氨基甲烷(Tris)缓冲液纯化人甲状腺素0.02mol/L,pH7.4水平1目标浓度范围:7pmol/L～13pmol/L水平2目标浓度范围:28pmol/L～52pmol/L校准信息卡二维码(内含校准信息)校准品、质控品靶值批特异,详见瓶标签.
名称主要组分浓度试剂1磷酸盐（PBS）缓冲液包被鼠源性甲状腺素单克隆抗体的免疫磁性微球0.05mol/L，pH7.4＞0.01%试剂2磷酸盐（PBS）缓冲液吖啶酯标记的甲状腺素抗原0.05mol/L，pH7.4＞10ng/mL校准品（液体，3水平）三羟甲基氨基甲烷（Tris）缓冲液纯化人甲状腺素0.02mol/L，pH7.4水平1目标浓度：0pmol/L水平2目标浓度：10pmol/L水平3目标浓度：40pmol/L质控品（液体，2水平）三羟甲基氨基甲烷（Tris）缓冲液纯化人甲状腺素0.02mol/L，pH7.4水平1目标浓度范围：7pmol/L～13pmol/L水平2目标浓度范围：28pmol/L～52pmol/L校准信息卡二维码（内含校准信息）校准品、质控品靶值批特异，详见瓶标签。
2 °C ~ 8 °C protected from light, valid for 12 months.
2℃～8℃避光保存，有效期12个月。
- Changes
- 产品过期日期变更为：2℃～8℃避光保存，有效期12个月。。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Free thyroxine detection kit (magnetic particle chemiluminescence immunoassay) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20242400556 and owned by Baiding Biological Engineering (Beijing) Co., Ltd.. The device was approved on October 18, 2024.
This page provides complete registration details including registrant information, province location (Beijing), 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.