PMA P220006S001

Device: VENTANA FOLR1 (FOLR1-2.1) RxDx Assay
Applicant: Ventana Medical Systems, Inc.
PMA number: P220006
Supplement: S001
Product code: QUL
Decision date: 2023-08-23
Classification: Medical Genetics
Generic name: Immunohistochemistry Assay, Antibody, FOLR1
Approval order statement: Approval to modify the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay to remove the Stain Intensity Reference (SIR) slide from the assay configuration.

Current openFDA PMA Record#

Device: VENTANA FOLR1 (FOLR1-2.1) RxDx Assay
Applicant: Ventana Medical Systems, Inc.
PMA number: P220006
Supplement: S001
Product code: QUL
Generic name: Immunohistochemistry Assay, Antibody, FOLR1
Decision date: 2023-08-23
Decision code: APPR
Date received: 2023-03-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to modify the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay to remove the Stain Intensity Reference (SIR) slide from the assay configuration.