China NMPA legacy archive 京械注准20242400554Thyroid Peroxidase Antibody Assay Kit (Chemiluminescent Immunoassay with Magnetic Microparticle)
- 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20242400554
- 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抗甲状腺过氧化物酶抗体的含量.
用于体外定量测定人血清中抗甲状腺过氧化物酶抗体的含量。
名称主要组分浓度试剂1磷酸盐(PBS)缓冲液包被鼠源性荧光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)缓冲液荧光素标记的甲状腺过氧化物酶抗原0.05mol/L,pH7.4＞0.1ug/mL试剂3磷酸盐(PBS)缓冲液吖啶酯标记的鼠源性抗人IgG抗体单克隆抗体0.05mol/L,pH7.4＞10ng/mL校准品(液体,3水平)三羟甲基氨基甲烷(Tris)缓冲液抗甲状腺过氧化物酶抗体0.02mol/L,pH7.4水平1目标浓度:0IU/mL水平2目标浓度:20IU/mL水平3目标浓度:200IU/mL质控品(液体,2水平)三羟甲基氨基甲烷(Tris)缓冲液抗甲状腺过氧化物酶抗体0.02mol/L,pH7.4水平1目标浓度范围:7IU/mL～13IU/mL水平2目标浓度范围:70IU/mL～130IU/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）缓冲液包被鼠源性荧光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）缓冲液荧光素标记的甲状腺过氧化物酶抗原0.05mol/L，pH7.4＞0.1ug/mL试剂3磷酸盐（PBS）缓冲液吖啶酯标记的鼠源性抗人IgG抗体单克隆抗体0.05mol/L，pH7.4＞10ng/mL校准品（液体，3水平）三羟甲基氨基甲烷（Tris）缓冲液抗甲状腺过氧化物酶抗体0.02mol/L，pH7.4水平1目标浓度：0IU/mL水平2目标浓度：20IU/mL水平3目标浓度：200IU/mL质控品（液体，2水平）三羟甲基氨基甲烷（Tris）缓冲液抗甲状腺过氧化物酶抗体0.02mol/L，pH7.4水平1目标浓度范围：7IU/mL～13IU/mL水平2目标浓度范围：70IU/mL～130IU/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
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