Product code QNH
- Device name
- Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay
- Medical specialty
- Hematology
- Device class
- 3
- Regulation number
- 864.1860
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- The DNA Mismatch Repair Protein Antibody is a qualitative immunohistochemical antibody intended for the assessment of mismatch repair (MMR) proteins in human clinical tissue specimens. The DNA Mismatch Repair Protein Antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P210001S016 | VENTANA MMR RxDx Panel | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2026-10-08 |
| P200019S014 | VENTANA MMR RxDx Panel | Ventana Medical Systems | 2026-10-08 |
| P250004S001 | MMR IHC Panel pharmDx (Dako Omnis) | Agilent Technologies, Inc. | 2026-09-11 |
| P210001S015 | VENTANA anti-MSH6 (SP93) Antibody | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2026-01-06 |
| P200019S013 | VENTANA anti-MSH6 (SP93) Antibody | Ventana Medical Systems | 2026-01-06 |
| P250004 | MMR IHC Panel pharmDx (Dako Omnis) | Agilent Technologies, Inc. | 2025-08-15 |
| P200019S012 | VENTANA MMR RxDx Panel | Ventana Medical Systems | 2025-06-20 |
| P210001S014 | VENTANA MMR RxDx Panel | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2025-04-17 |
| P200019S011 | VENTANA MMR RxDx Panel | Ventana Medical Systems | 2025-04-17 |
| P200019S010 | VENTANA MMR RxDx Panel | Ventana Medical Systems | 2024-12-20 |
| P210001S013 | VENTANA MMR RxDx Panel | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2024-12-18 |
| P210001S011 | VENTANA MMR RxDx Panel (Solid Tumors with dMMR status) | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2024-01-26 |
| P200019S009 | VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) | Ventana Medical Systems | 2024-01-26 |
| P210001S010 | VENTANA MMR RxDx Panel, VENTANA ANTI-MLH1 (M1), VENTANA ANTI-MSH6 (SP93), VENTANA ANTI-MSH2 (G219-1129), VENTANA ANTI-PM | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2023-11-08 |
| P200019S008 | VENTANA MMR RxDx Panel, VENTANA ANTI-MLH1 (M1), VENTANA ANTI-MSH6 (SP93), VENTANA ANTI-MSH2 (G219-1129), VENTANA ANTI-PM | Ventana Medical Systems | 2023-11-08 |
| P210001S009 | VENTANA MMR RxDx Panel Solid Tumors with dMMR status) | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2023-08-29 |
| P200019S007 | VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) | Ventana Medical Systems | 2023-08-29 |
| P210001S008 | VENTANA MMR RxDx Panel | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2023-05-26 |
| P200019S006 | VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) | Ventana Medical Systems | 2022-11-10 |
| P210001S006 | VENTANA MMR RxDx Panel (Solid Tumors with dMMR status) | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2022-07-29 |
| P200019S005 | VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) | Ventana Medical Systems | 2022-07-29 |
| P210001S004 | VENTANA MMR RxDx Panel Solid Tumors with dMMR status) | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2022-07-21 |
| P200019S004 | VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) | Ventana Medical Systems | 2022-07-21 |
| P210001S002 | VENTANA MMR RxDx Panel | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2022-06-16 |
| P210001S003 | VENTANA MMR RxDx Panel | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2022-06-10 |
| P200019S003 | VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) | Ventana Medical Systems | 2022-06-10 |
| P210001S005 | VENTANA MMR RxDx Panel | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2022-05-20 |
| P210001S001 | VENTANA MMR RxDx Panel | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2022-03-21 |
| P210001 | VENTANA MMR RxDx Panel | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2021-08-17 |
| P200019 | VENTANA MMR RxDx Panel | Ventana Medical Systems | 2021-04-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05700575005213 | MLH1 IHC pharmDx (Dako Omnis) | AGILENT TECHNOLOGIES, INC. | 2025-08-27 |
| 05700575005220 | MSH2 IHC pharmDx (Dako Omnis) | AGILENT TECHNOLOGIES, INC. | 2025-08-27 |
| 05700575005237 | MSH6 IHC pharmDx (Dako Omnis) | AGILENT TECHNOLOGIES, INC. | 2025-08-27 |
| 05700575005244 | PMS2 IHC pharmDx (Dako Omnis) | AGILENT TECHNOLOGIES, INC. | 2025-08-27 |
| 05700575005251 | MMR Negative Control Reagent, Mouse (Dako Omnis) | AGILENT TECHNOLOGIES, INC. | 2025-08-27 |
| 05700575005268 | MMR Negative Control Reagent, Rabbit (Dako Omnis) | AGILENT TECHNOLOGIES, INC. | 2025-08-27 |
| 07613336100561 | VENTANA ANTI-MLH1 (M1) Mouse Monoclonal Primary Antibody | Ventana Medical Systems, Inc. | 2018-02-08 |
| 07613336100578 | VENTANA Anti MSH6 (SP93) Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. | 2018-02-08 |
| 07613336100585 | VENTANA Anti MSH2 (G219-1129) Mouse Monoclonal Primary Antibody | Ventana Medical Systems, Inc. | 2018-02-08 |
| 07613336100592 | VENTANA Anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody | Ventana Medical Systems, Inc. | 2018-02-08 |