# Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay
> **Product code: QNH** · Class III — High Risk (PMA approval required, life-sustaining) · Hematology · 21 CFR 864.1860
## Classification
- **FDA Product Code:** QNH
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** 21 CFR 864.1860
- **Review panel:** PA
- **Medical specialty:** Hematology
- **Submission type:** 2
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 4
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QNH)
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