厦门集庆医疗集研发、生产和销售为一体的体外诊断产品专业公司，企业主要负责人有20多年的IVD产品研发和生产的经历，于2016年作为厦门双百人才，带领团队通过多年的耕耘，形成了能满足日产30-50万人份检测试剂能力的符合医疗器械GMP要求生产体系，包括配套的十万级生产净化车间、万级检验净化车间及配套包装车间及仓储场地，并通过了ISO13485体系认证。拥有完整的的胶体金和核酸检测试剂生产线，主要从事了结核抗体胶体金检测试剂盒及核酸检测试剂盒、HCG/LH二联检试剂盒、新冠病毒检测试剂盒的开发。为应对新冠疫情，公司已成功开发出IgM/IgG检测卡、抗原检测卡、PCR试剂盒及配套的样本采集和核酸提取试剂，建立了企业内部控制盘，满足了日常验证要求，产品已按国家药监局相关规定，启动临床试验工作。产品在8月底前已在十多个国家和地区进行评估验证和使用，得到客户广泛认可。
公司新冠产品已获得国内出口资质，已获得CE认证及欧盟备案，已申请巴西ANVISA和美国EUA认证。
Xiamen Jiqing Biomedical Technology Co., Ltd. Focus on IVD products, include R & D, production and sales. The founder in charge of the company has more than 20 years of experience in R & D and production of IVD products. In 2016, as a talents in Xiamen, he led the team through years of hard work to form a production system that can meet the GMP requirements of MDD with a daily capacity of 300000-500000 tests, including supporting facilities. Our company has passed ISO13485 system certification for D level production and clean workshop, C level inspection and purification workshop, supporting packaging workshop and warehouse. It has a complete production line of colloidal gold and nucleic acid detection reagents, mainly engaged in the development of tuberculosis antibody colloidal gold detection kit and nucleic acid detection kit, HCG / LH two joint detection kit and 2019-nCoV detection kit. In response to the new crown epidemic, the company has successfully developed IgM, IgG and IgM / IgG detection cards, nucleic acid extraction and PCR kits, established the internal control panel of the enterprise, and met the daily verification requirements. The product has started clinical trials in accordance with the relevant provisions of the NMPA. Before the end of June, the products have been evaluated, verified and used in more than ten countries and regions, and have been widely recognized by customers.
The company's Novel coronavirus products have obtained domestic export qualification, CE certification , and have applied for Brazil ANVISA and US EUA certification
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