PMA P250004
- Device
- MMR IHC Panel pharmDx (Dako Omnis)
- Applicant
- Agilent Technologies, Inc.
- Product code
- QNH
- Decision date
- 2025-08-15
- Generic name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
- Approval order statement
- For In Vitro Diagnostic Use.MMR IHC Panel pharmDx (Dako Omnis) is a qualitative immunohistochemical (IHC) assay intended for use in the assessment of mismatch repair (MMR) proteins (MLH1, PMS2, MSH2, and MSH6) in formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue using EnVision FLEX visualization system on Dako Omnis automated staining instrument. MMR IHC Panel pharmDx (Dako Omnis) consists of MLH1 IHC pharmDx (Dako Omnis), PMS2 IHC pharmDx (Dako Omnis), MSH2 IHC pharmDx (Dako Omnis), and MSH6 IHC pharmDx (Dako Omnis), which must be used together to identify MMR deficient CRC patients.MMR IHC Panel pharmDx (Dako Omnis) is indicated as an aid to identify MMR deficient CRC patients eligible for treatment with OPDIVO® (nivolumab) alone or OPDIVO (nivolumab) in combination with YERVOY® (ipilimumab).
Current openFDA PMA Record#
- Device
- MMR IHC Panel pharmDx (Dako Omnis)
- Applicant
- Agilent Technologies, Inc.
- PMA number
- P250004
- Product code
- QNH
- Generic name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
- Decision date
- 2025-08-15
- Decision code
- APPR
- Date received
- 2025-02-18
- Approval order statement
- For In Vitro Diagnostic Use.MMR IHC Panel pharmDx (Dako Omnis) is a qualitative immunohistochemical (IHC) assay intended for use in the assessment of mismatch repair (MMR) proteins (MLH1, PMS2, MSH2, and MSH6) in formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue using EnVision FLEX visualization system on Dako Omnis automated staining instrument. MMR IHC Panel pharmDx (Dako Omnis) consists of MLH1 IHC pharmDx (Dako Omnis), PMS2 IHC pharmDx (Dako Omnis), MSH2 IHC pharmDx (Dako Omnis), and MSH6 IHC pharmDx (Dako Omnis), which must be used together to identify MMR deficient CRC patients.MMR IHC Panel pharmDx (Dako Omnis) is indicated as an aid to identify MMR deficient CRC patients eligible for treatment with OPDIVO® (nivolumab) alone or OPDIVO (nivolumab) in combination with YERVOY® (ipilimumab).