The COVID-19 IgM/IgG Antibody Test Kit, produced by Beijing Homa Biological Engineering Co.,Ltd, had got the CE certificate and got the approval to enter the list of officially nominated export enterprises by Ministry of Commerce.
The COVID-19 IgM/IgG Antibody Test Kit, developed independently by Beijing Homa Biological Engineering Co.,Ltd, had got the approval to enter the list of officially nominated export enterprises by Ministry of Commerce (White-List).
取得国外标准认证或注册的医疗物资生产企业清单 动态更新:2020年6月1日 下载 | |||
Name List of Medical Devices and Supplies Companies with Certification/Authorization from other Countries | |||
number | manufacturing compan | Unified Social Credit Code | Overseas Authorization |
新型冠状病毒检测试剂Coronavirus Reagent Test kits |
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| |
1 | 北京万泰生物药业股份有限公司 | 91110114600067778R | 欧盟CE |
2 | 深圳市锦瑞生物科技有限公司 | 91440300766350741W | 欧盟CE |
3 | 安徽福贸生物科技有限公司 | 91340225MA2TENM49Y | 欧盟CE |
4 | 安徽深蓝医疗科技股份有限公司 | 913401005501903714 | 欧盟CE |
227 | 北京豪迈生物工程股份有限公司 | 911101016000459665 | 欧盟CE |
The COVID-19 IgG/IgM Antibody Test Kit (colloidal gold immunochromatographic assay), which is approved to export this time, one card with two test results, can obtain the results within 15 minutes, simultaneously meeting the demand for rapid detection of IgG/IgM antibody. Due to ensure the performance and quality of our products, during the most severe epidemic period in Wuhan, our company went to a third-grade hospital in Wuhan for clinical experiments and verification of reagents for four times, and obtained satisfying clinical experimental data, which ensured the excellent performance and accurate and reliable results of our products.
At present, the global COVID-19 epidemic continues to spread and the situation is grim. This time our novel Coronavirus antibody test kit has been approved for export, will contribute to the global epidemic prevention and control work.
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