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,…

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.

TGA Public Summary