HSA · registration DE0510358Biocartis Idylla™ GeneFusion Panel
- Registration number
- DE0510358
- Model name
- Idylla GeneFusion Panel; Idylla GeneFusion Panel Test Type Package (TTP); Idylla Instrument; Idylla Console
- Model identifier
- A0120/6; Idylla GeneFusion Panel Test Type Package (TTP); P0010; P1010
- Registration date
- February 19, 2025
- Source update date
- April 07, 2026
- Risk class
- Class C
- Product owner
- Biocartis NV
- Registrant / registration holder
- ANDAMAN MEDICAL PTE. LTD.
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 address
- Generaal De Wittelaan 11B, 2800 Mechelen, Belgium
- Registrant address
- 300 TAMPINES AVENUE 5, #09-02, INCOME AT TAMPINES JUNCTION, Singapore 529653
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.