Device Dossier
therascreen KRAS RGQ PCR Kit (Cat No. 870081) - Acquired genetic alteration IVDs
Device Dossier for therascreen KRAS RGQ PCR Kit (Cat No. 870081) - Acquired genetic alteration IVDs (CT929 - Acquired genetic alteration IVDs, Class 3,…
- GMDN category: CT929 - Acquired genetic alteration IVDs
Intended purpose
IVDs intended for the detection of somatic mutations in oncogenes using nucleic acids extracted from human specimens to guide targeted therapy
Functional description
The therascreen KRAS RGQ PCR Kit is a real-time qualitative PCR assay for the detection of 7 somatic mutations in codons 12 and 13 of the human KRAS oncogene using the Rotor-Gene Q MDx instrument.