Anti-β2 Glycoprotein 1 Antibody IgA Test Kit (Magnetic Microparticle Chemiluminescence Method)
- Device class
- Class II
- Model specifications
- 50 servings/box, 100 servings/box50人份/盒，100人份/盒
- Approval department
- Jiangsu Provincial Drug Administration江苏省药品监督管理局
- Registration number
- 苏械注准20202401241
- Approval date
- June 02, 2022
- Expiry date
- November 18, 2025
- Name
- HOB Biotech Group Corp., Ltd.江苏浩欧博生物医药股份有限公司
- Province/Region
- Jiangsu江苏
- Address
- 101, Building C6, Bionanopark, No. 218 Xinghu Street, Suzhou Industrial Park苏州工业园区星湖街218号生物纳米园C6栋101
- Production address
- 苏州工业园区星湖街218号生物纳米园C6栋101，C8栋402，C9栋101，C10栋；苏州工业园区福泾田路68号A座6楼602室
This kit is used to quantitatively detect the concentration of anti-β2 glycoprotein 1 antibody IgA in human serum and plasma samples in vitro.
本试剂盒用于体外定量检测人血清、血浆样本中抗β2糖蛋白1抗体IgA的浓度。
Component Name Main Component Loading Capacity Data Card 50 servings/box 100 servings/box R1 0.01M PBS (pH 7.4, containing 1% BSA) 1×2.5mL/bottle 1×5mL/bottle 1 M magnetic particles (0.1-1mg/ml) conjugated β2-GP1 antigen (human plasma, 0.1-5μg/ml) dissolved in 0.02M Tris (pH 8.0) 1×2.5mL/bottle 1×5mL/bottle R2 AP-labeled anti-human IgA (0.1-1μg/ml) ml) dissolved in 0.05 M MES (pH 6.0) buffer 1×6.75 mL/bottle 1×13.5 mL/bottle
组份名称 主要成分 装量 数据卡 50人份/盒 100人份/盒 R1 0.01M PBS（pH 7.4，含1%BSA） 1×2.5mL/瓶 1×5mL/瓶 1张M 偶联β2-GP1抗原（人血浆，0.1-5μg/ml）的磁微粒（0.1-1mg/ml）溶于0.02M Tris（pH 8.0）中 1×2.5mL/瓶 1×5mL/瓶 R2 AP-标记抗人IgA（0.1-1μg/ml）溶于0.05M MES（pH 6.0）缓冲液中 1×6.75mL/瓶 1×13.5mL/瓶
The production date and expiration date are shown in the label. Unopened reagent 2~8 °C sealed and protected from light for 12 months, opened or machine reagent 2~8 °C for 28 days
生产日期、失效日期见标签。未开封试剂2~8℃ 密封避光保存12个月开封或在机试剂2~8℃ 28天
Access comprehensive regulatory information for Anti-β2 Glycoprotein 1 Antibody IgA Test Kit (Magnetic Microparticle Chemiluminescence Method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 苏械注准20202401241 and owned by HOB Biotech Group Corp., Ltd.. The device was approved on June 02, 2022.
This page provides complete registration details including registrant information, province location (Jiangsu), 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.