PMA P200019S014

Device: VENTANA MMR RxDx Panel
Applicant: Ventana Medical Systems
PMA number: P200019
Supplement: S014
Product code: QNH
Decision date: 2026-10-08
Classification: Pathology
Generic name: Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
Approval order statement: Approval to add a new anti-PMS2 clone, VENTANA anti-PMS2 (SP487) Rabbit Monoclonal Primary Antibody, to the VENTANA MMR RxDx Panel for use on the BenchMark ULTRA and BenchMark ULTRA PLUS platforms

Current openFDA PMA Record#

Device: VENTANA MMR RxDx Panel
Applicant: Ventana Medical Systems
PMA number: P200019
Supplement: S014
Product code: QNH
Generic name: Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
Decision date: 2026-10-08
Decision code: APPR
Date received: 2025-12-12
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to add a new anti-PMS2 clone, VENTANA anti-PMS2 (SP487) Rabbit Monoclonal Primary Antibody, to the VENTANA MMR RxDx Panel for use on the BenchMark ULTRA and BenchMark ULTRA PLUS platforms