Singapore HSA registration DE0510358
Biocartis Idylla™ GeneFusion Panel
Singapore·CLASS C IVD·Biocartis NV·Registered February 19, 2025Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Pathology
Registration information
- Registration Number
- DE0510358
- Registration Date
- February 19, 2025
- Retention Due Date
- February 18, 2026
Product description
The Biocartis Idylla™ GeneFusion Panel is a fully automated in vitro diagnostic test intended for the qualitative detection of specific gene fusions of ALK, ROS1, RET as well as MET exon 14 skipping. The Idylla™ GeneFusion Panel is intended for use with formalin-fixed, paraffin-embedded (FFPE) tumor tissue sections from patients with non-small cell lung cancer (NSCLC). The Idylla™ GeneFusion Panel covers the entire process from sample to result, including fully integrated RNA and DNA extraction, reverse transcription of mRNA, real- time PCR amplification and detection, data analysis, and result reporting. The Idylla™ GeneFusion Panel is for use by healthcare professionals for identifying the panel gene rearrangements for patients with NSCLC, to predict the most appropriate treatment options. The Idylla™ GeneFusion Panel is not intended to diagnose NSCLC.
Product Owner
- Name
- Biocartis NV
- Short Name
- Biocartis NV
- Address
- Generaal De Wittelaan 11B, 2800 Mechelen, BELGIUM
Registrant
- Address
- 300 Tampines Avenue 5, #09-02, SINGAPORE 529653
Importer
- Address
- 100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Model information
- Model Name(s)
- Idylla GeneFusion Panel Idylla GeneFusion Panel Test Type Package (TTP) Idylla Instrument Idylla Console
- Model Identifier(s)
- A0120/6 Idylla GeneFusion Panel Test Type Package (TTP) P0010 P1010
About this record
Access comprehensive regulatory information for Biocartis Idylla™ GeneFusion Panel 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 DE0510358 and owned by Biocartis NV. The device was registered on February 19, 2025.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD