Antithyroid peroxidase antibody assay kit (chemiluminescence immunoassay)
- Device class
- Class II
- Model specifications
- 50 servings/box; 100 servings/box
- Approval department
- Beijing Municipal Drug Administration
- Registration number
- 京械注准20232400528
- Approval date
- September 01, 2023
- Expiry date
- August 31, 2028
- Province/Region
- Beijing
- Address
- 101, 1st to 3rd floor, Building 19, No. 2 Huanke Middle Road, Beijing Economic and Technological Development Zone (Tongzhou), Beijing
- Production address
- 北京市通州区环科中路2号院19号楼-1至3层
It is used for in vitro quantitative determination of the content of thyroid peroxidase antibody in human serum or plasma.
用于体外定量测定人血清或血浆中甲状腺过氧化物酶抗体的含量。
name Composition Loading Reagent M Superparamagnetic particles coated with TPO antigen > 0.1 g/L ProClin 300,0.1% Serves 50: 3mL; Serves 100: 6mL Reagent 1 ProteinA-alkaline phosphatase marker, > 0.1 mg/L ProClin 300,0.1% Serves 50: 3mL; Serves 100: 6mL Reagent 2 Tris buffer, 50 mmol/L ProClin 300,0.1% Serves 50: 3mL; Serves 100: 6mL Calibrators (Optional) 3 levels, containing anti-thyroid peroxidase antibodies, stabilizers, preservatives Target Concentration Range: S1:0-20IU/mL;S2:20-100IU/mL;S3:100-1000IU/mL 1mL Calibration information A QR code containing information about the main calibration curve / Note: Calibrator assignment is batch-specific, and the target value of each lot is detailed in the label.
名称 组成成分 装量 试剂M 包被着TPO抗原的超顺磁性微粒,>0.1g/L ProClin 300,0.1% 50人份:3mL; 100人份:6mL 试剂1 ProteinA-碱性磷酸酶标记物,>0.1mg/L ProClin 300,0.1% 50人份:3mL; 100人份:6mL 试剂2 Tris缓冲液,50mmol/L ProClin 300,0.1% 50人份:3mL; 100人份:6mL 校准品 (选配) 3水平,含抗甲状腺过氧化物酶抗体,稳定剂,防腐剂 目标浓度范围: S1:0-20IU/mL;S2:20-100IU/mL;S3:100-1000IU/mL 1mL 校准信息 二维码,包含主校准曲线信息 / 注:校准品赋值具有批特异性,每批次靶值详见标签。
The reagents are stored at 2 °C ~ 8 °C
试剂在2℃~8℃条件下存放有
- Appendix
- 产品技术要求、说明书
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