|
Device | VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) |
Generic Name | Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay |
Regulation Number | 864.1860 |
Applicant | Ventana Medical Systems 1910 E Innovation Park Drive Tucson, AZ 85755 |
PMA Number | P200019 |
Supplement Number | S004 |
Date Received | 02/16/2022 |
Decision Date | 07/21/2022 |
Product Code |
QNH |
Advisory Committee |
Pathology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for (i) a change in expiry dating from Hematoxylin and Hematoxylin II and (ii) implementation of a revised process for creating reference slides used in Surveillance and Stability testing of Hematoxylin and Hematoxylin II. |