Biocartis Idylla™ MSI Test - HSA Registration DE0504441
Access comprehensive regulatory information for Biocartis Idylla™ MSI 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 DE0504441 and owned by Biocartis NV. The device was registered on May 05, 2020.
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™ MSI Test is an in-vitro diagnostic Test intended for the qualitative detection of a novel panel of 7 monomorphic biomarkers for identification of colorectal cancers with microsatellite instability (MSI). The Idylla™ MSI Test uses formalin-fixed, paraffin-embedded (FFPE) tissue sections from human colorectal cancer (CRC) tissue, from which nucleic acids are liberated, then analyzed by PCR amplification and high-resolution melting detection. The Idylla™ MSI Test automates the entire process from FFPE sample preparation to reporting of MSI status. The test is not directly conclusive or prescriptive for labelled use of any specific therapeutic product. The Idylla™ MSI Test should not be used for diagnosis of colorectal cancer.