|
Device | VENTANA MMR RxDx Panel (Solid Tumors with dMMR status) |
Generic Name | Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay |
Regulation Number | 864.1860 |
Applicant | Ventana Medical Systems Inc (Roche Tissue Diagnostics) 1910 E. Innovation Park Drive Tucson, AZ 85755 |
PMA Number | P210001 |
Supplement Number | S011 |
Date Received | 10/30/2023 |
Decision Date | 01/26/2024 |
Product Code |
QNH |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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). |