abanalitica 产品代理
abanalitica 产品代理
AB ANALITICA的我们特别了解新兴技术和诊断市场的需求，并不断投资于我们的研发部门，该部门从事微生物学、病毒学、肿瘤学和遗传学的高级分子生物学诊断。我们的主要能力包括基于分子生物学方法定性和定量测定核酸的诊断、生物银行管理系统的开发和实施，以及使用呼吸测试和稳定同位素的体内和体外诊断。
AB ANALITICA根据UNI EN ISO 9001和UNI EN ISO 13485认证，用于传染病、血液学、肿瘤学和基因检测、药物遗传学、呼吸测试、下一代基因测序（NGS）领域的体外诊断医疗器械（IVD）的设计、开发、生产和贸易，用于体外诊断的样品制备自动化解决方案，以及这些系统的技术援助。此外，AB ANALITICA还销售和提供体外诊断仪器的技术援助，并为临床化学分析提供实验室服务。
AB ANALITICA was established in the year 1990 in Padua in the Veneto region (north-east Italy) and is a company is specialized in the development and the sale of diagnostic systems for professional use.
We at AB ANALITICA are particularly aware of emerging technologies and the requirements of the diagnostic market, and are continuously investing in our research and development department, which is involved in advanced molecular biology diagnostics in microbiology, virology, oncology, and genetics. Our main competences cover diagnostics based on qualitative and quantitative determination of nucleic acids by molecular biology methods, the development and implementation of biobanking management systems as well as in vivo and in vitro diagnostics using breath test and stable isotopes.
AB ANALITICA has a sales agent network that covers the entire Italian territory and we collaborate with local distributors in many export countries.
AB ANALITICA is certified according to UNI EN ISO 9001 and UNI EN ISO 13485 for the design, development, production and trade of in-vitro diagnostic medical devices (IVD) in the fields of infectious diseases, in hematology, in oncology and genetic testing, in pharmacogenetics, breath tests, Next Gene Sequencing (NGS), automated solutions for sample preparation for in-vitro diagnostics as well as technical assistance for these systems. In addition AB ANALITICA markets and provides technical assistance for instruments for in-vitro diagnostics and offers laboratory services for clinical chemistry analyses.
All our products for diagnostic use have been certified according to directive 98/79/EC on medical in-vitro diagnostic devices. Our product lines include:
HCV genotyping kits (Hepatitis C Virus), conforming to Annex II, list A, of directive 98/79/EC
End-Point PCR and Real-Time PCR kits for detection of infection markers of Chlamydia trachomatis and Cytomegalovirus, conforming to Annex II, list B, of directive 98/79/EC
PCR kits for determination of genetic predisposition based on HLA typing, conforming to Annex II, list B, of directive 98/79/EC
We at AB ANALITICA ensure both efficacy and optimal performance of our devices using Internal Controls and by regularly participating in External Quality Assessment programs.
AB ANALITICA is also certified by the CFDA (China Food and Drug Administration) for HPV diagnostics, has registered products as ASRs (Analyte Specific Reagents) with the FDA (U.S. Food and Drug Administration) and is authorized to export in 40 different countries.
