Biocartis Idylla KRAS Mutation Test - HSA Registration DE0500910
Access comprehensive regulatory information for Biocartis Idylla KRAS Mutation Test in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0500910 and owned by Biocartis NV. The device was registered on November 24, 2017.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The Idylla™ KRAS Mutation Test, performed on the Biocartis Idylla™ System, is an in vitro diagnostic test for the qualitative detection of mutations in codons 12, 13, 59, 61, 117 or 146 of the KRAS oncogene. The Idylla™ KRAS Mutation Test, from sample to result, starts with formalin-fixed, paraffin-embedded (FFPE) human colorectal cancer (CRC) tissue to liberate DNA for subsequent real-time PCR amplification and detection. The Idylla™ KRAS Mutation Test is intended to determine the tumor KRAS mutation status of patients with metastatic colorectal cancer at diagnosis and to facilitate treatment decisions within a multidisciplinary team. The Idylla™ KRAS Mutation Test is not intended to diagnose colorectal cancer.