Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay
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.