QNH — Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay Class III
FDA product code QNH covers "Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay", a Class III medical device regulated under 21 CFR 864.1860. Submissions are reviewed by the Hematology panel.
Classification Details
- Product Code
- QNH
- Device Class
- Class III
- Regulation Number
- 864.1860
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
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.