altona Diagnostics receives CE-IVD mark for HCV RT-PCR test
Hamburg, February 07, 2019
altona Diagnostics GmbH, today announced the launch of the AltoStar® HCV RT-PCR Kit 1.5, an in vitro diagnostic test, based on real-time RT-PCR technology, for the detection and quantification of hepatitis C virus (HCV) specific RNA (genotypes 1 to 6). The assay is designed for use with the AltoStar® Automation System AM16, the AltoStar® Purification Kit 1.5, the AltoStar® Internal Control 1.5 and the Bio-Rad CFX96™ Deep Well Real-Time PCR Detection System.
The AltoStar® HCV RT-PCT Kit 1.5 represents altona Diagnostics first List A test, in compliance with the in vitro Diagnostic Directive (IVDD) 98/79/EC.
“We are very proud to announce the launch of our first List A product with HCV, and this is the first in a series of List A tests soon to follow” said Dr. Ulrich Spengler, altona Diagnostic’s Managing Director.
For more information Go-to-specifications AltoStar® HCV RT-PCR Kit 1.5 CE
Launch AltoStar® HCV Rt-PCR Kit 1.5 - February 2019
Press Release AltoStar HCV RT-PCR Kit 1.0-EN_2019-02-07pdf