MDSAP certificate Renewal

We are pleased to announce that Alifax S.r.l. has successfully renewed the ISO 13485 MDSAP certificate issued by TUV SUD America Inc. , which qualifies our Quality Management System compliant with the IVD-related regulations of the 5 countries adhering to the Medical Device Single Audit Program: Australia TGA Brazil ANVISA Health Canada Japan MHLW/PMDA USA…

First Publications on I-dOne

First Publications on I-dOne 🗓️ 26 SEPTEMBER Rapid bacterial identification from positive blood cultures by infrared spectroscopy using short-term incubation  74th Annual Meeting of the German Society for Hygiene and Microbiology e.V. (DGHM) 5–7 September 2022 Berlin.  “Off-label” trial study (not present in the current intended use) conducted by the team of Prof Wendel of the…

NEW installation of HB&L at the National Medical Research Center, Moscow

Installation of HB&L at the National Medical Research Center. Academician Burdenko, Moscow   Started another new study of HB&L analyzer at the National Medical Research Center. Academician Burdenko, Moscow.   The purposes of the clinical evaluation are:   Rapid screening of cerebrospinal fluid Rapid screening of urine Rapid formation of microorganism yield for further investigation and application,…

Urine screening with HB&L analyzer at Helix laboratory in Yekaterinburg, Russia

HB&L: automation and standardization of urine culture   The Helix Laboratories Services unified the approach for the automation and standardization of the URINE COLTURE screening with the HB&L analyzer across all of its locations. Following the laboratories of St. Petersburg and Moscow, Helix equipped his bacteriological laboratory with another HB&L analyzer in Yekaterinburg.     Helix Laboratories