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Singapore HSA registration DE0510544

Ventana VENTANA FOLR1 (FOLR1-2.1) RxDx Assay

Singapore flagSingapore·CLASS C IVD·Ventana Medical Systems, Inc.·Registered April 03, 2025
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Pathology
Registration information
Registration Number
DE0510544
Registration Date
April 03, 2025
Retention Due Date
April 02, 2026
Product description
VENTANA FOLR1 (FOLR1-2.1) RxDx Assay is a qualitative IHC assay using mouse monoclonal anti-FOLR1, clone FOLR1-2.1, intended for laboratory use in the assessment of folate receptor alpha (FOLR1) protein in FFPE epithelial ovarian, fallopian tube, or primary peritoneal cancer tissue specimens by light microscopy. This assay is for use with OptiView DAB IHC Detection Kit for staining on a BenchMark ULTRA instrument. FOLR1 expression clinical cut-off is ≥ 75% viable tumor cells (TC) with membrane staining at moderate and/or strong intensity levels. This assay is indicated as an aid in identifying patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer who may be eligible for treatment with ELAHERE (mirvetuximab soravtansine). Test results of the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. This product is intended for IVD use.
Product Owner
Name
Ventana Medical Systems, Inc.
Short Name
Ventana Medical Systems, Inc.
Address
1910 East Innovation Park Drive, Tucson, AZ, 85755, UNITED STATES
Registrant
Name
Roche Diagnostics Asia Pacific Pte Ltd
Address
8 KALLANG AVENUE, APERIA, #10-01/09, SINGAPORE 339509
Importer
Name
Roche Diagnostics Asia Pacific Pte Ltd
Address
8 KALLANG AVENUE, APERIA, #10-01/09, SINGAPORE 339509
Model information
Model Name(s)
VENTANA FOLR1 (FOLR1-2.1) RxDx Assay Negative Control (Monoclonal)
Model Identifier(s)
740-5065 / 07727917001 760-2014 / 05266670001
About this record

Access comprehensive regulatory information for Ventana VENTANA FOLR1 (FOLR1-2.1) RxDx Assay 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 DE0510544 and owned by Ventana Medical Systems, Inc.. The device was registered on April 03, 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