Biocartis Idylla EGFR Mutation Test - HSA Registration DE0501853
Access comprehensive regulatory information for Biocartis Idylla EGFR 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 DE0501853 and owned by Biocartis NV. The device was registered on July 09, 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 Biocartis Idylla™ EGFR Mutation Test performed on the Biocartis Idylla™ System, is an in vitro diagnostic test intended for the qualitative detection of exon 18 (G719A/S/C), exon 21 (L858R, L861Q), exon 20 (T790M, S768I) mutations, exon 19 deletions and exon 20 insertions in the EGFR oncogene. The Idylla™ EGFR Mutation Test uses formalin-fixed, paraffin-embedded (FFPE) tissue sections from human non-small cell lung cancer (NSCLC) tissue. The Idylla™ EGFR Mutation Test covers the entire process from FFPE sample to result, including fully integrated sample preparation, liberation of nucleic acids, real-time PCR amplification and detection, and data analysis.