Ventana VENTANA FOLR1 (FOLR1-2.1) RxDx Assay - HSA Registration DE0510544
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.
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.