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Medical Devices / Submissions and Approvals

Altona Gains CE-IVD Mark for Hep C Diagnostic Kit

Feb. 11, 2019
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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.

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