QNH
- Product code
- QNH
- Device name
- Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay
- Device class
- Class 3
- 21 CFR
- 21 CFR 864.1860
- Medical specialty
- Hematology
- Marketing pathway
- PMA
FDA classification 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.
Official FDA classification page: QNH
Classification and pathway per current FDA publications. Data from openFDA (CC0).