Sacace Biotechnologies S.r.l.
Sacace Biotechnologies S.r.l. is an innovative Italian company, located in Como, Lombardia founded in 2001.
Sacace supplies its products to hospitals and laboratories through a global network of distributors located in more than 60 countries all over the world. Sacace incorporates all functions required – research & development, manufacturing, logistics, marketing and sales of an extensive line of molecular biology diagnostic tests that accurately screen for the presence of disease in human, animal and food fields – to provide adequate support to its customers.
Sacace develops, manufactures and sells through distributors more than 140 complete kits for human, veterinary and food diagnostics. The kits produced by Sacace include all the reagents for nucleic acid extraction, reverse transcription, amplification of specific genomic regions and detection by Agarose gel electrophoresis, Real Time amplification and End Point detection.
The products are designed to provide ease-of-use, they are CE marked in compliance with Directive 98/79EC and incorporate the highest quality reagents to ensure consistency, reliability and long shelf life.
Quality assurance is the cornerstone of the Company’s success. The quality management has obtained ISO 9001:2008 and ISO 13485:2012 certifications and all aspects of product design and manufacture are carried out in accordance with these standards.
Sacace has obtained the CE mark certificate for in vitro diagnostic medical devices according to Annex II, List B of the Directive 98/79/EC.
Sacace has just obtained the CE mark certificate for HCV Real-TM Quant DX and HBV Real-TM Quant DX in vitro diagnostic medical devices according to Annex II, List A of the Directive 98/79/EC.
Sacace has just obtained the CE mark certificate for HIV Real-TM Quant DX in vitro diagnostic medical device according to Annex II, List A of the Directive 98/79/EC.