Biocartis Idylla NRAS-BRAF Mutation Test - HSA Registration DE0501059
Access comprehensive regulatory information for Biocartis Idylla NRAS-BRAF 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 DE0501059 and owned by Biocartis NV. The device was registered on January 03, 2018.
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™ NRAS-BRAF 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, 146 of the NRAS gene and codon 600 of the BRAF gene. The Idylla™ NRAS-BRAF Mutation Test, from sample to result, starts with the liberation of DNA from formalin-fixed, paraffin-embedded (FFPE) human colorectal cancer tissue, followed by real-time PCR amplification and detection.