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Singapore HSA registration DE0501059

Biocartis Idylla NRAS-BRAF Mutation Test

Singapore flagSingapore·CLASS C IVD·Biocartis NV·Registered January 03, 2018
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Pathology
Registration information
Registration Number
DE0501059
Registration Date
January 03, 2018
Change Notification Approval Date
July 11, 2024
Retention Due Date
January 02, 2026
Product description
The Idylla™ NRAS-BRAF Mutation Test, performed on the Biocartis Idylla™ System, is an in vitro diagnostic test for the qualitative detection of mutations in codons 12, 13, 59, 61, 117, 146 of the NRAS gene and codon 600 of the BRAF gene. The Idylla™ NRAS-BRAF Mutation Test, from sample to result, starts with the liberation of DNA from formalin-fixed, paraffin-embedded (FFPE) human colorectal cancer tissue, followed by real-time PCR amplification and detection.
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 NRAS-BRAF Mutation Test Idylla Instrument Idylla Console
Model Identifier(s)
A0030/6 P0010 P1010
About this record

Access comprehensive regulatory information for Biocartis Idylla NRAS-BRAF 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 DE0501059 and owned by Biocartis NV. The device was registered on January 03, 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.

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