CLIA

Padova, Italy

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. Through our highly qualified and committed researchers as well as constant collaboration with research institutes, universities, and hospitals we have gained the scientific knowledge and experience that allow AB ANALITICA to develop and produce high-quality, innovative and safe diagnostic systems that are in line with the most recent medical guidelines. 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. Production Our in vitro diagnostics (IVD) are made in our Padua branch. Over 2400 sqm of laboratories are reserved for Production and R&D. The entire production cycle is subject to strict quality controls.