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Singapore HSA registration DE0501853

Biocartis Idylla EGFR Mutation Test

Singapore flagSingapore·CLASS C IVD·Biocartis NV·Registered July 09, 2018
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Pathology
Registration information
Registration Number
DE0501853
Registration Date
July 09, 2018
Change Notification Approval Date
December 11, 2024
Retention Due Date
July 08, 2025
Product description
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.
Product Owner
Name
Biocartis NV
Short Name
Biocartis NV
Address
Generaal De Wittelaan 11B, 2800 Mechelen, BELGIUM
Registrant
Name
ANDAMAN MEDICAL PTE. LTD.
Address
300 Tampines Avenue 5, #09-02, SINGAPORE 529653
Importer
Name
SPD SCIENTIFIC PTE LTD
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Model information
Model Name(s)
Idylla EGFR Mutation Test Idylla Instrument Idylla Console
Model Identifier(s)
A0060/6 P0010 P1010
About this record

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD