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China NMPA legacy archive 京械注准20232400528

Antithyroid peroxidase antibody assay kit (chemiluminescence immunoassay)

抗甲状腺过氧化物酶抗体测定试剂盒(化学发光免疫分析法)
Beijing Diagreat Biotechnologies Co., Ltd.Class IINMPAApproved September 01, 2023
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
50 servings/box; 100 servings/box
50人份/盒;100人份/盒
Approval department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration information
Registration number
京械注准20232400528
Approval date
September 01, 2023
Expiry date
August 31, 2028
Registrant
Name
Beijing Diagreat Biotechnologies Co., Ltd.
北京丹大生物技术有限公司
Province/Region
Beijing
北京
Address
101, 1st to 3rd floor, Building 19, No. 2 Huanke Middle Road, Beijing Economic and Technological Development Zone (Tongzhou), Beijing
北京市北京经济技术开发区(通州)环科中路2号院19号楼1至3层101
Production facility
Production address
北京市通州区环科中路2号院19号楼-1至3层
Intended use
English

It is used for in vitro quantitative determination of the content of thyroid peroxidase antibody in human serum or plasma.

中文

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。

Structure and composition
English

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.

中文

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。

Storage conditions and expiration
English

The reagents are stored at 2 °C ~ 8 °C

中文

试剂在2℃~8℃条件下存放有

Additional information
Appendix
产品技术要求、说明书
About this record

This static archive preserves historical registration fields and translations for Antithyroid peroxidase antibody assay kit (chemiluminescence immunoassay), registration 京械注准20232400528. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.