China NMPA legacy archive 京械注准20242400552Thyroglobulin Assay 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.
- Approval department
- Beijing Municipal Drug Administration
- Registration number
- 京械注准20242400552
- Approval date
- October 18, 2024
- Expiry date
- October 17, 2029
- Province/Region
- Beijing
- Address
- No. 11, Dongying Road, Zhaoquanying Town, Shunyi District, Beijing
- Production address
- 北京市顺义区赵全营镇兆丰产业基地东盈路11号
用于体外定量测定人血清中甲状腺球蛋白的含量.
用于体外定量测定人血清中甲状腺球蛋白的含量。
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球蛋白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鼠源性甲状腺球蛋白单克隆抗体0.05mol/L,pH7.4＞10ng/mL校准品(液体,3水平)三羟甲基氨基甲烷(Tris)缓冲液纯化甲状腺球蛋白抗原0.02mol/L,pH7.4水平1目标浓度:0ng/mL水平2目标浓度:2ng/mL水平3目标浓度:100ng/mL质控品(液体,2水平)三羟甲基氨基甲烷(Tris)缓冲液纯化甲状腺球蛋白抗原0.02mol/L,pH7.4水平1目标浓度范围0.7ng/mL～1.3ng/mL水平2目标浓度范围:35ng/mL～65ng/mL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球蛋白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鼠源性甲状腺球蛋白单克隆抗体0.05mol/L，pH7.4＞10ng/mL校准品（液体，3水平）三羟甲基氨基甲烷（Tris）缓冲液纯化甲状腺球蛋白抗原0.02mol/L，pH7.4水平1目标浓度：0ng/mL水平2目标浓度：2ng/mL水平3目标浓度：100ng/mL质控品（液体，2水平）三羟甲基氨基甲烷（Tris）缓冲液纯化甲状腺球蛋白抗原0.02mol/L，pH7.4水平1目标浓度范围0.7ng/mL～1.3ng/mL水平2目标浓度范围：35ng/mL～65ng/mL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
This static archive preserves historical registration fields and translations for Thyroglobulin Assay Kit (Magnetic Particle Chemiluminescence Immunoassay), registration 京械注准20242400552. It does not establish current authorization or complete current product details.
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