Device Dossier
Acquired genetic alteration IVDs
Device Dossier for Acquired genetic alteration IVDs (CT929 - Acquired genetic alteration IVDs, Class 3, sponsor Cepheid Holdings). ARTG record, intended…
- GMDN category: CT929 - Acquired genetic alteration IVDs
Intended purpose
The Xpert BCR-ABL Monitor and Ultra Assays are real-time RT-PCR (reverse transcription-polymerase chain reaction) assays intended as an aid in the monitoring of the BCR-ABL mRNA transcript in peripheral blood of patients with chronic myelogenous leukemia (CML).