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One Step SARS-CoV-2 Ag Card Test

Formello (RM), Italy

Immunochromatographic assay for qualitative detection of SARS-CoV-2 antigen using nasopharyngeal swabs from symptomatic patients.

Manufactured by

Formello (RM), Italy

Futura System Group S.r.l. is an Italian company located in the suburbs of Rome that manufactures and distributes latest generation and high-quality in vitro diagnostics (I.V.D.) for Clinical Chemistry, Coagulation, Immunoturbidimetry , Serology and other products for the Analysis Laboratories. Since 1984 the Company has operated in the diagnostic market for Clinical Laboratories, and has always aimed at the people s health. Its mission is developing innovative in-vitro diagnostic products with high stability and sensitivity, providing the analytical laboratories with results ever more accurate in order to better service the patients. Products Futura Systems Group has developed a catalogue of reagents and instruments to satisfy the needs of the Analysis Laboratories. All Clinical Chemistry and Immunoturbidimetry Reagents are liquid, stable and ready to use. The company provides ready-to-use diagnostic kits with own brand, or semi-manufactured products as bulk reagents or O.E.M. (unlabeled vials). Futura System Group s.r.l. is ready to help its distributors by supplying contractual and administrative documentation, in order to obtain the registration in every country across the world. Research To Future Systems Group, research is the key to identify and develop new reagents and products for the IVD market. The team of chemists and biologists is constantly working on improving the products which have been developed already as well as developing new IVD with performances that better meet the latest needs of the market. Production Futura System Group S.r.l production department uses advanced instruments and equipment. Chemists and biologists who take care of the Quality Control use the best practices and monitor the complete manufacturing cycle so that the high quality and efficiency of diagnostics is guaranteed with low costs. This leads to a faster and effective answer to the customers needs. Marketing Futura System Group s.r.l. directly deals with labs analysis with its sales force in the Italian market. In addition, the Company works worldwide with specialized dealers. The Company is market-oriented and aims at supplying quality, services and convenience, considering the importance of customers satisfaction. The after-sales policy offers a telephone hotline and training sessions for the specialized dealers. All the technical staff is highly qualified and knowledgeable in dealing with the issues that its customers laboratories may present. Futura System Group s.r.l. has a significant market share and sells its products in many countries, applying carefully and punctually its marketing policy which is based on the latest technologies as well as on the customers needs. As an exhibitor, the Company attends some of the most important international medical fairs, for example Medica in Dusseldorf, Arab Health in Dubai, LabIndonesia in Jakarta. Quality The company is EN ISO 9001 and EN ISO 13485 certified. The reagents are CE certified and manufactured according to the IVD law 98/79/CE and the 1271/2008 (CLP) Directive. The high quality of diagnostics is verified and granted by the application of an internal Quality Control Protocol, which monitors the whole manufacturing cycle, from raw materials to finished kits. Every step related to the processing and the storage is verified and validated in order to provide the clients with high-performing products and constant quality. The Internal Quality Controls department issues a report for every lot. Samples of each lot are stored until its expiration date, in case further control is requested. There is a partnership with one of the most important university in Rome, which cooperates in the research phase and also deals with Quality Tests. Social Responsibility Futura System Group safeguards people s health. The company is actively involved in helping non-profit companies that are health care providers in the developing countries. Furthermore, the Company holds training sessions addressed to the staff who work in the analytical laboratories in order to improve their knowledge.This will result in a further improvement of the developing countries. The Ethic Code Through the application of its Ethic Code, Futura System Group always pursues high standards of ethics and code of conduct. The company is committed to the application of high-profile behavioural norms in order to make every day worth. The company aims at being recognized as a virtuous one with a long tradition in the research as it has always been engaged in providing people worldwide with a better quality of life.

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