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Singapore HSA registration DE0504441

Biocartis Idylla™ MSI Test

Singapore flagSingapore·CLASS C IVD·Biocartis NV·Registered May 05, 2020
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Pathology
Registration information
Registration Number
DE0504441
Registration Date
May 05, 2020
Change Notification Approval Date
July 11, 2024
Retention Due Date
May 04, 2026
Product description
The Idylla™ MSI Test is an in-vitro diagnostic Test intended for the qualitative detection of a novel panel of 7 monomorphic biomarkers for identification of colorectal cancers with microsatellite instability (MSI). The Idylla™ MSI Test uses formalin-fixed, paraffin-embedded (FFPE) tissue sections from human colorectal cancer (CRC) tissue, from which nucleic acids are liberated, then analyzed by PCR amplification and high-resolution melting detection. The Idylla™ MSI Test automates the entire process from FFPE sample preparation to reporting of MSI status. The test is not directly conclusive or prescriptive for labelled use of any specific therapeutic product. The Idylla™ MSI Test should not be used for diagnosis of colorectal cancer.
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 MSI Test Idylla Instrument Idylla Console
Model Identifier(s)
A0100/6 P0010 P1010
About this record

Access comprehensive regulatory information for Biocartis Idylla™ MSI 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 DE0504441 and owned by Biocartis NV. The device was registered on May 05, 2020.

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