PMA P210001S011

Device: VENTANA MMR RxDx Panel (Solid Tumors with dMMR status)
Applicant: Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
PMA number: P210001
Supplement: S011
Product code: QNH
Decision date: 2024-01-26
Classification: Pathology
Generic name: Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
Approval order statement: approval for a change in expiry dating (extension to the stability from 12 months to 18 months) for Hematoxylin (PN 760-2021) and Hematoxylin II (PN 790-2208).

Current openFDA PMA Record#

Device: VENTANA MMR RxDx Panel (Solid Tumors with dMMR status)
Applicant: Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
PMA number: P210001
Supplement: S011
Product code: QNH
Generic name: Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
Decision date: 2024-01-26
Decision code: APPR
Date received: 2023-10-30
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for a change in expiry dating (extension to the stability from 12 months to 18 months) for Hematoxylin (PN 760-2021) and Hematoxylin II (PN 790-2208).