Antithyroid peroxidase antibody assay kit (chemiluminescence immunoassay)
- Device class
- Class II
- Model specifications
- 50 servings/box; 100 servings/box50人份/盒；100人份/盒
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20232400528
- Approval date
- September 01, 2023
- Expiry date
- August 31, 2028
- 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 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
Access comprehensive regulatory information for Antithyroid peroxidase antibody assay kit (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20232400528 and owned by Beijing Diagreat Biotechnologies Co., Ltd.. The device was approved on September 01, 2023.
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.