www.fdanews.com/articles/190176-altona-gains-ce-ivd-mark-for-hep-c-diagnostic-kit
Altona Gains CE-IVD Mark for Hep C Diagnostic Kit
February 8, 2019
Altona Diagnostics received the CE Mark for its AltoStar hepatitis C virus reverse transcription polymerase chain reaction (RT-PCR) diagnostic kit.
The kit uses real-time PCR technology to detect and quantify virus-specific RNA with genotypes one to six.
The diagnostic device is for use with the AltoStar automation system and Bio-Rad Laboratories’ CFX96 real-time PCR detection system.